Trial Outcomes & Findings for The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries (NCT NCT04192747)
NCT ID: NCT04192747
Last Updated: 2025-03-24
Results Overview
The primary endpoint of the BIOADAPTOR RCT is Target Lesion Failure (TLF), which is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated TLR
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
445 participants
Primary outcome timeframe
12 Months
Results posted on
2025-03-24
Participant Flow
Study recruitment and enrollment took place at 34 global centers including 14 in Japan and 20 in Europe between December 2020 to February 2022. A total of 445 patients with de novo coronary artery lesions were enrolled and randomly assigned to either the DynamX arm or the Resolute Onyx arm.
Participant milestones
| Measure |
Elixir Bioadaptor (ELX1805J)
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
222
|
|
Overall Study
COMPLETED
|
221
|
215
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Elixir Bioadaptor vs. The Onyx Stent in De Novo Native Coronary Arteries
Baseline characteristics by cohort
| Measure |
Elixir Bioadaptor (ELX1805J)
n=223 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=222 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Total
n=445 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 10.1 • n=7 Participants
|
66.6 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
347 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
110 Participants
n=5 Participants
|
113 Participants
n=7 Participants
|
223 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsThe primary endpoint of the BIOADAPTOR RCT is Target Lesion Failure (TLF), which is a composite endpoint defined as cardiac death, target-vessel MI, and Clinically-Indicated TLR
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=215 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Target Lesion Failure (TLF)
|
1.81 percentage of participants
Interval 0.5 to 4.57
|
2.79 percentage of participants
Interval 1.03 to 5.97
|
SECONDARY outcome
Timeframe: Through 12 months post-procedureTLF is a composite endpoint defined as cardiovascular death, target-vessel MI, and Clinically-Indicated TLR
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=215 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Target Lesion Failure (TLF)
|
1.8 percentage of participants
Interval 0.5 to 4.6
|
2.8 percentage of participants
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: Through 12 monthsPopulation: The denominator reflects the number of evaluable participants for the outcome measure
Overall cardiovascular outcomes from the patient's perspective. This endpoint is a composite endpoint that includes all-cause mortality (cardiac and non-cardiac), stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel)
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=222 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=216 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Patient Oriented Clinical Endpoint
|
6.8 percentage of participants
Interval 3.8 to 10.9
|
7.9 percentage of participants
Interval 4.7 to 12.3
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
A composite of all-cause mortality, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=222 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=216 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Composite of All-cause Mortality
|
6.8 percentage of participants
Interval 3.8 to 10.9
|
7.9 percentage of participants
Interval 4.7 to 12.3
|
SECONDARY outcome
Timeframe: Through 12 monthsComposite of cardiac death, target vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR)
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=215 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Composite of Cardiovascular Death, TVMI and ID-TVR Revascularization
|
1.8 percentage of participants
Interval 0.5 to 4.6
|
3.7 percentage of participants
Interval 1.6 to 7.2
|
SECONDARY outcome
Timeframe: Through 12 monthsComposite of cardiovascular death, stroke, MI (target vessel and non-target vessel) and revascularization (target vessel and non-target vessel)
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=215 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Cardiovascular Death, Stroke, MI and Revascularization
|
6.3 percentage of participants
Interval 3.5 to 10.4
|
7.4 percentage of participants
Interval 4.3 to 11.8
|
SECONDARY outcome
Timeframe: Through 12 monthsComposite of cardiovascular death, MI (target vessel or non-target vessel) and revascularization (target vessel or non-target vessel)
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=215 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Cardiovascular Death, MI and Revascularization
|
6.3 percentage of participants
Interval 3.5 to 10.4
|
7.4 percentage of participants
Interval 4.3 to 11.8
|
SECONDARY outcome
Timeframe: Through 12 months post-procedureNumber of Patients with Clinically Indicated Target Lesion Revascularization (CI-TLR)
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Clinically Indicated Target Lesion Revascularization (CI-TLR)
|
0.9 percentage of participants
Interval 0.1 to 3.2
|
0.5 percentage of participants
Interval 0.0 to 2.6
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
Target lesion revascularization
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Target Lesion Revascularization (TLR)
|
1.4 percentage of participants
Interval 0.3 to 3.9
|
0.9 percentage of participants
Interval 0.1 to 3.4
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
Re-PCI or CABG of the target vessel due to in-segment restenosis or other complications
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Target Vessel Revascularization (TVR)
|
1.4 percentage of participants
Interval 0.3 to 3.9
|
1.9 percentage of participants
Interval 0.5 to 4.7
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
Re-PCI or CABG in the target vessel due to restenosis or other complications
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Clinically Indicated TVR (CI-TVR)
|
0.9 percentage of participants
Interval 0.1 to 3.2
|
1.4 percentage of participants
Interval 0.3 to 4.1
|
SECONDARY outcome
Timeframe: Through 12 months post procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
Revascularization of the target vessel or non-target vessel due to in-segment restenosis or other complications
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Revascularization (Target Vessel or Non-target Vessel)
|
5.4 percentage of participants
Interval 2.8 to 9.3
|
5.2 percentage of participants
Interval 2.6 to 9.1
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
CK post procedure is twice the upper limit of the reference value or higher, with new pathological Q-wave on 2 or more contiguous ECG leads and if CK-MB is measured, CK-MB is positive, if no CKMB then troponin is positive.
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Q-wave MI
|
0.0 percentage of participants
Interval 0.0 to 1.7
|
0.9 percentage of participants
Interval 0.1 to 3.4
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
CK post procedure is twice the upper limit of the reference value or higher, without new pathological Q-waves. If CK-MB is measured, CK-MB is positive, if no CKMB then troponin is positive.
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Non Q-wave MI
|
0.9 percentage of participants
Interval 0.1 to 3.2
|
0.9 percentage of participants
Interval 0.1 to 3.4
|
SECONDARY outcome
Timeframe: Through 12 months post procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
MI is defined as per the Academic Research Consortium (ARC-2) criteria
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With MI (Target Vessel or Non-target Vessel)
|
1.4 percentage of participants
Interval 0.3 to 3.9
|
1.9 percentage of participants
Interval 0.5 to 4.7
|
SECONDARY outcome
Timeframe: Through 12 months post procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
MI is defined as per the Academic Research Consortium (ARC-2) criteria
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Target Vessel MI
|
1.4 percentage of participants
Interval 0.3 to 3.9
|
1.9 percentage of participants
Interval 0.5 to 4.7
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
As defined per the Academic Research Consortium (ARC-2) criteria
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=222 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=216 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With All-cause Mortality
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
1.4 percentage of participants
Interval 0.3 to 4.0
|
SECONDARY outcome
Timeframe: Through 12 months post procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
As defined as per the Academic Research Consortium (ARC-2) criteria
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=215 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Cardiovascular Death
|
0.0 percentage of participants
Interval 0.0 to 1.7
|
0.9 percentage of participants
Interval 0.1 to 3.3
|
SECONDARY outcome
Timeframe: Through 12 months post procedureTarget Vessel Related Death or MI
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=215 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Composite of Cardiovascular Death or Target Vessel MI
|
1.4 percentage of participants
Interval 0.3 to 3.9
|
2.8 percentage of participants
Interval 1.0 to 6.0
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
Target vessel or non-target vessel related death or MI
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=222 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=216 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Composite of All-cause Death or MI
|
1.8 percentage of participants
Interval 0.5 to 4.5
|
3.2 percentage of participants
Interval 1.3 to 6.6
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
Any Death, any MI and any Target Vessel Revascularization
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=222 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=216 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Composite of All-cause Death, MI (Target Vessel or Non-target Vessel), or TVR
|
2.7 percentage of participants
Interval 1.0 to 5.8
|
4.6 percentage of participants
Interval 2.2 to 8.3
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
Defined as per the Academic Research Consortium (ARC-2) criteria
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=214 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Composite of Probable or Definite Stent Thrombosis
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
0.5 percentage of participants
Interval 0.0 to 2.6
|
SECONDARY outcome
Timeframe: Through 12 months post-procedurePopulation: The denominator reflects the number of evaluable participants for the outcome measure
Defined as per the Academic Research Consortium (ARC-2) criteria
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=214 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Probable Stent Thrombosis
|
0 percentage of participants
Interval 0.0 to 1.7
|
0.5 percentage of participants
Interval 0.0 to 2.6
|
SECONDARY outcome
Timeframe: Through 12 monthsPopulation: The denominator reflects the number of evaluable participants for the outcome measure
Defined as per the Academic Research Consortium (ARC-2) criteria
Outcome measures
| Measure |
Elixir Bioadaptor (ELX1805J)
n=221 Participants
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=213 Participants
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Percentage of Participants With Definite Stent Thrombosis
|
0.5 percentage of participants
Interval 0.0 to 2.5
|
0 percentage of participants
Interval 0.0 to 1.7
|
Adverse Events
Elixir Bioadaptor (ELX1805J)
Serious events: 60 serious events
Other events: 128 other events
Deaths: 1 deaths
Medtronic Resolute Onyx Stent
Serious events: 44 serious events
Other events: 124 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Elixir Bioadaptor (ELX1805J)
n=223 participants at risk
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=222 participants at risk
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Cardiac disorders
Revascularization - CABG
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Death - Cardiovascular
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Death - Non-Cardiovascular
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
MI
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Revascularization Re-PCI
|
5.4%
12/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
4.5%
10/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Stent Thrombosis - Definite
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Stent Thrombosis - Probable
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Stent Thrombosis - Possible
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
CVA - TIA
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
CVA - Ischemic
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
CVA - Haemorrhagic
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Bleeding
|
1.3%
3/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.4%
3/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Other
|
18.4%
41/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
11.3%
25/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Death - Unknown
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
Other adverse events
| Measure |
Elixir Bioadaptor (ELX1805J)
n=223 participants at risk
The Elixir Bioadaptor (ELX1805J) 2.25 - 4.0 mm diameter and 14,15,18, 23, 28, 32 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
Medtronic Resolute Onyx Stent
n=222 participants at risk
The Medtronic Resolute Onyx Stent 2.25 - 4.0 mm diameter and 15, 18, 22, 30, 34 and 38 mm in length
Percutaneous Coronary Intervention: Percutaneous coronary intervention of de novo native coronary artery lesions
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Angina pectoris
|
2.2%
5/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
2.3%
5/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Angina unstable
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Atrial fibrillation
|
3.1%
7/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.4%
3/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Atrial tachycardia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Cardiac failure
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Chest discomfort
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Chest pain
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.3%
3/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Dyspnoea
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Myopericarditis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Prinzmetal angina
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Thoracic pain
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Congenital, familial and genetic disorders
Congenital spinal stenosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Ear and labyrinth disorders
Vertigo
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Eye disorders
Cataract
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Eye disorders
Eyelid ptosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.4%
3/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Barrett"s oesophagus
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Constipation
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Diverticulum itestial haemorrhagic
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Gastric polyps
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Gastritis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Gastroesophageal Disease
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Gastrointestinal angiectasia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Gastrointestinal Hemmorhages
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Haematemesis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Haematochezia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Melanea
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Nausea
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Toothache
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Gastrointestinal disorders
Vomiting
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Chest discomfort
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Chest pain
|
3.6%
8/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
5.9%
13/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Fatigue
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
General physical health deterioration
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Influenza like illness
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Malaise
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Non-cardiac chest pain
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.4%
3/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Peripheral swelling
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Vascular stent stenosis
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
General disorders
Vascular stent thrombosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
COVID-19
|
3.6%
8/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
5.9%
13/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Cellulitis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Coronavirus infection
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Gastrointestinal infection
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Herpes dermatitis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Nasopharyngitis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Sinusitis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Urinary tract infection
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Infections and infestations
Viral infection
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.2%
5/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
2.3%
5/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Coronary artery dissection
|
2.2%
5/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
4.5%
10/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Coronary artery occlusion
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.4%
3/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Post procedural hypotension
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Postoperative delirium
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Reperfusion injury
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Vascular access site bruising
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Vascular access site complication
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Vascular graft thrombosis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Vessel perforation
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Vessel puncture site haematoma
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Vessel puncture site haemorrhage
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Injury, poisoning and procedural complications
Vessel puncture site swelling
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Angiogram
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Blood pressure increased
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
ECG signs of myocardial ischaemia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Hepatic enzyme increased
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Magnetic resonance imaging abnormal
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Myocardial necrosis marker increased
|
4.0%
9/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.8%
4/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Prostatic specific antigen increased
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Troponin I increased
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Troponin increased
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Investigations
Ureteroscopy
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
2.7%
6/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.3%
3/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.4%
3/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.4%
3/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gliosarcoma
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lip neoplasm
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer metastatic
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal neoplasm
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal papilloma
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Amnesia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Dizziness
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Headache
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Lethargy
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Parkinson's disease
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Partial seizures
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Spinal claudication
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Psychiatric disorders
Anxiety
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Psychiatric disorders
Insomnia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.3%
3/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Renal and urinary disorders
Calculus urinary
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Renal and urinary disorders
Haematuria
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.8%
4/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.7%
6/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
2.3%
5/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
3/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Skin and subcutaneous tissue disorders
Eczema asteatotic
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Surgical and medical procedures
Coronary artery bypass
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.90%
2/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Surgical and medical procedures
Craniotomy
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Surgical and medical procedures
Finger amputation
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Surgical and medical procedures
Keratoplasty
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Surgical and medical procedures
Knee arthroplasty
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Surgical and medical procedures
Skin cyst excision
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Acute coronary syndrome
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Aneurysm arteriovenous
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Haematoma
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Hypertension
|
1.3%
3/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
1.4%
3/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Hypertensive crisis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Hypotension
|
0.90%
2/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Iliac artery stenosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Intermittent claudication
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Internal haemorrhage
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Orthostatic hypotension
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Peripheral artery stenosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Peripheral vein thrombosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Syncope
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.00%
0/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Vascular disorders
Varicose vein
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
|
Nervous system disorders
Lumbar spinal stenosis
|
0.45%
1/223 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
0.45%
1/222 • Through 12-month post procedure
Site reported AE and SAE's were reported by sites using MedDRA preferred terms. All study endpoint-related adverse events through 12 months, including death, myocardial Infarction, revascularization, stent thrombosis, and stroke, were adjudicated. All-cause mortality was calculated based off the number of evaluable participants at 12 months. Site reported SAE and AE table were calculated based on the total number of enrolled participants from the start of the trial.
|
Additional Information
Tina Cordaro, Sr. Director, Clinical Trials
Elixir Medical Corporation
Phone: 585-360-7270
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place