Trial Outcomes & Findings for Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease (NCT NCT05755711)
NCT ID: NCT05755711
Last Updated: 2026-01-22
Results Overview
Target lesion failure (TLF) at 30 days defined as a composite of cardiac death, myocardial infarction (per SCAI definition for peri-procedural MI; per 4th Universal Definition for spontaneous MI beyond discharge) attributable to target vessel (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR).
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
399 participants
Primary outcome timeframe
within 30 days of index procedure
Results posted on
2026-01-22
Participant Flow
Participant milestones
| Measure |
Intent to Treat
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Overall Study
STARTED
|
399
|
|
Overall Study
COMPLETED
|
389
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Intent to Treat
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Overall Study
Death
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
N=398 because 1 participant did not have a have a height measurement to calculate BMI
Baseline characteristics by cohort
| Measure |
Intent-to-Treat (ITT)
n=399 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Age, Continuous
|
73.1 years
STANDARD_DEVIATION 9.9 • n=399 Participants
|
|
Sex: Female, Male
Female
|
399 Participants
n=399 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=399 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
57 Participants
n=399 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
299 Participants
n=399 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
43 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
Asian
|
10 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
41 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
White
|
319 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not specified
|
23 Participants
n=399 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=399 Participants
|
|
Subject has Childbearing Potential
|
9 Participants
n=399 Participants
|
|
Body Mass Index
|
27.9 kg/m2
STANDARD_DEVIATION 5.8 • n=398 Participants • N=398 because 1 participant did not have a have a height measurement to calculate BMI
|
|
BMI Categories
Underweight (below 18.5)
|
9 Participants
n=398 Participants • N=398 because 1 participant did not have a have a height measurement to calculate BMI
|
|
BMI Categories
Healthy weight (18.5 - 24.9)
|
126 Participants
n=398 Participants • N=398 because 1 participant did not have a have a height measurement to calculate BMI
|
|
BMI Categories
Overweight (25 - 29.9)
|
140 Participants
n=398 Participants • N=398 because 1 participant did not have a have a height measurement to calculate BMI
|
|
BMI Categories
Obesity (30 or greater)
|
123 Participants
n=398 Participants • N=398 because 1 participant did not have a have a height measurement to calculate BMI
|
PRIMARY outcome
Timeframe: within 30 days of index procedureTarget lesion failure (TLF) at 30 days defined as a composite of cardiac death, myocardial infarction (per SCAI definition for peri-procedural MI; per 4th Universal Definition for spontaneous MI beyond discharge) attributable to target vessel (TV-MI), or ischemia-driven target lesion revascularization (ID-TLR).
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=397 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Primary Safety Endpoint: Number of Participants With Target Lesion Failure (TLF) at 30 Days
|
46 Participants
|
PRIMARY outcome
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedureProcedural Success defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions (core laboratory assessed) and without in-hospital TLF (CEC adjudicated).
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=390 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Primary Effectiveness Endpoint: Procedural Success
|
341 Participants
|
SECONDARY outcome
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedureAngiographic Success defined as stent delivery with ≤30% residual stenosis and without serious angiographic complications.
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=420 Lesions
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Angiographic Success (≤30% Residual Stenosis)
|
407 Lesions
|
SECONDARY outcome
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedureProcedural Success defined as stent delivery with a residual stenosis \<50% in all target lesions (core laboratory assessed) and without in-hospital TLF.
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=390 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Procedural Success
|
342 Participants
|
SECONDARY outcome
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedureAngiographic Success defined as stent delivery with \< 50% residual stenosis and without serious angiographic complications.
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=420 Lesions
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Angiographic Success (< 50% Residual Stenosis)
|
408 Lesions
|
SECONDARY outcome
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedureSerious angiographic complications defined as severe dissection (Type D to F), perforation, abrupt closure, and persistent slow flow or persistent no reflow.
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=420 Lesions
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Serious Angiographic Complications
|
6 Lesions
|
SECONDARY outcome
Timeframe: within 30 days of index procedureMajor Adverse Cardiac Events (MACE) defined as a composite of cardiac death, myocardial infarction (per SCAI definition for periprocedural MI; per 4th Universal Definition for spontaneous MI beyond discharge), and target vessel revascularization. All MACE were adjudicated by an independent CEC.
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=397 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Major Adverse Cardiac Events (MACE)
|
48 Participants
|
SECONDARY outcome
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedure.All death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) in-hospital
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=399 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Stent Thrombosis (ARC definite)
|
2 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Stent Thrombosis (ARC probable)
|
1 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Death
|
4 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Cardiac Death
|
3 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
MI
|
39 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
TV-MI
|
39 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Procedural MI
|
38 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Nonprocedural MI
|
1 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
ID-TVR
|
5 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
ID-TLR
|
5 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Non-ID-TLR
|
0 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Non-ID-TVR
|
0 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Revascularizations (ID)
|
5 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Revascularizations (non-ID)
|
0 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Any Revascularizations
|
14 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Stent Thrombosis (ARC definite or probable)
|
3 Participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedureAll death, cardiac death, MI, TV-MI, procedural and nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, all revascularizations (ID and non-ID), and stent thrombosis (ARC definite, probable, definite or probable) through 30 days
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=397 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Death
|
8 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Cardiac Death
|
4 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
MI
|
44 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
TV-MI
|
42 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Procedural MI
|
38 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Nonprocedural MI
|
8 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
ID-TVR
|
5 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
ID-TLR
|
5 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
ID-non-TLR
|
0 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
ID-non-TVR
|
0 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Revascularizations (ID)
|
5 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Revascularizations (Non-ID)
|
0 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Any Revascularizations
|
22 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Stent Thrombosis (ARC definite)
|
2 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Stent Thrombosis (ARC probable)
|
2 Participants
|
|
All Death, Cardiac Death, MI, TV-MI, Procedural and Nonprocedural MI, ID-TVR, ID-TLR, ID-non-TLR, ID-non-TVR, All Revascularizations, and Stent Thrombosis
Stent Thrombosis (ARC definite or probable)
|
4 Participants
|
SECONDARY outcome
Timeframe: 12-24 hours post procedure or at discharge, whichever is earlier, but at least 4 hours post procedureMI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI at all timepoints.
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=399 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
MI (Myocardial Infarction)
Spontaneous MI (>48hrs, 4th Universal Definition: Type 4a)
|
1 Participants
|
|
MI (Myocardial Infarction)
TLF (Target Lesion Failure)
|
5 Participants
|
|
MI (Myocardial Infarction)
Peri-procedural MI (<48hrs, SCAI Definition)
|
38 Participants
|
SECONDARY outcome
Timeframe: within 30 days of index procedureMI rates and all composite endpoints (TLF, MACE) will also be reported using the 4th Universal Definition for peri-procedural and spontaneous MI at all timepoints.
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=397 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
MI (Myocardial Infarction)
Peri-procedural MI (<48hrs, SCAI Definition)
|
38 Participants
|
|
MI (Myocardial Infarction)
Spontaneous MI (>48hrs, 4th Universal Definition: Type 4a)
|
8 Participants
|
|
MI (Myocardial Infarction)
TLF (Target Lesion Failure)
|
46 Participants
|
SECONDARY outcome
Timeframe: From baseline to within 30 days of index procedureAngina symptoms assessed as a change from baseline (at each time period) by Seattle Angina Questionnaire (SAQ-7). Summary score; 0 to 24 represents poor health status; 25 to 49 represents fair; 50 to 74 represents good; 75 to 100 represents excellent.
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=353 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Angina Symptoms Assessed by Seattle Angina Questionnaire (SAQ-7)
|
93.8 score on a scale
Interval 77.5 to 100.0
|
SECONDARY outcome
Timeframe: From baseline to within 30 days of index procedureQuality of life assessed by EQ-5D-5L as a change from baseline (at each time period). Summary score; ranges from 0-100; 100 represents the best health you can imagine; 0 represents the worst.
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=352 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Quality of Life Assessed by EQ-5D-5L
|
7.8 score on a scale
Standard Deviation 20.9
|
SECONDARY outcome
Timeframe: From baseline to within 30 days of index procedureQuality of life assessed by Generalized Anxiety Disorder Questionnaire (GAD-7) as a change from baseline. Total score calculated by summing points (0-3) for each of the seven questions, yielding a total score from 0-21 (at each time period). Minimal Anxiety (0-4); Mild Anxiety (5-9 ); Moderate Anxiety (10-14 ); Severe Anxiety (≥15).
Outcome measures
| Measure |
Intent-to-Treat (ITT)
n=353 Participants
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Quality of Life Assessed by Generalized Anxiety Disorder Questionnaire (GAD-7)
|
2.0 score on a scale
Interval 0.0 to 5.0
|
Adverse Events
Intent to Treat (ITT)
Serious events: 88 serious events
Other events: 21 other events
Deaths: 8 deaths
Serious adverse events
| Measure |
Intent to Treat (ITT)
n=399 participants at risk
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Angina pectoris
|
2.3%
9/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Acute myocardial infarction
|
1.0%
4/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Atrial fibrillation
|
1.0%
4/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Cardiac failure
|
1.3%
5/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Cardiac arrest
|
1.0%
4/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Coronary artery dissection
|
1.5%
6/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Pericardial effusion
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Angina unstable
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Bradycardia
|
0.75%
3/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Coronary artery perforation
|
0.75%
3/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Myocardial infarction
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Coronary artery thrombosis
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Palpitations
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Gastrointestinal disorders
Retroperitoneal haematoma
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Gastrointestinal disorders
Dysphagia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Gastrointestinal disorders
Retroperitoneal haemorrhage
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
General disorders
Cardiac death
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
General disorders
Extravasation
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
General disorders
Pyrexia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Infections and infestations
Pneumonia
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Infections and infestations
COVID-19
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Infections and infestations
Influenza
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Infections and infestations
Septic shock
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Infections and infestations
Clostridium difficile infection
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Infections and infestations
Sepsis
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Infections and infestations
Viral infection
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Infections and infestations
Pneumonia influenzal
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
1.0%
4/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Vascular access site discharge
|
0.75%
3/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Fall
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Periprocedural myocardial infarction
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Post procedural myocardial infarction
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Vascular access site haemorrhage
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Investigations
Blood pressure decreased
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Investigations
Haemoglobin decreased
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Investigations
Heart rate irregular
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Investigations
Troponin increased
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Nervous system disorders
Dizziness
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Nervous system disorders
Ischaemic stroke
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Product Issues
Device malfunction
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Psychiatric disorders
Agitation
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Psychiatric disorders
Anxiety
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Psychiatric disorders
Delirium
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Psychiatric disorders
Mental status changes
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.75%
3/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Renal and urinary disorders
End stage renal disease
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Vascular disorders
Distributive shock
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.50%
2/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Vascular disorders
Hypotension
|
1.3%
5/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Vascular disorders
Arterial perforation
|
0.75%
3/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Vascular disorders
Deep vein thrombosis
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Vascular disorders
Aortic dissection
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Vascular disorders
Atherosclerotic plaque rupture
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Vascular disorders
Haematoma
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Vascular disorders
Hypertension
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Vascular disorders
Peripheral vascular disorder
|
0.25%
1/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
Other adverse events
| Measure |
Intent to Treat (ITT)
n=399 participants at risk
The primary analysis population will be the Intent-to-Treat (ITT) cohort which includes all enrolled subjects.
|
|---|---|
|
Cardiac disorders
Angina pectoris
|
2.8%
11/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
|
Injury, poisoning and procedural complications
Vascular access site haematoma
|
2.5%
10/399 • 30 Days
All AE information will be collected from enrollment through the 30 day follow-up visit. Reporting will be carried out in accordance with national regulations. AEs will be followed until the event has resolved (in the case of permanent impairment, the event will be followed until it stabilizes, and the overall clinical outcome has been ascertained). Any AEs that meet IRB/EC reporting requirements must be reported per the institution's policy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding study results for a period that is more than 45 days but less than or equal to 90 days from the date that the communication is submitted to the sponsor for review. The sponsor cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER