Trial Outcomes & Findings for Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study (NCT NCT02419521)
NCT ID: NCT02419521
Last Updated: 2019-04-03
Results Overview
In-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
8 Months
Results posted on
2019-04-03
Participant Flow
Participant milestones
| Measure |
Device
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
74
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Medtronic RESOLUTE ONYX Core (2.25 mm - 4.0 mm) Clinical Study
Baseline characteristics by cohort
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
46 Participants
n=5 Participants
|
|
Age, Continuous
|
66.1 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
75 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 MonthsIn-stent late lumen loss at 8-months post-procedure as measured by quantitative coronary angiography
Outcome measures
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
In-stent Late Lumen Loss as Measured by Quantitative Coronary Angiography
|
0.24 mm
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 8 MonthsOutcome measures
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Cardiac Death
|
0 Participants
|
SECONDARY outcome
Timeframe: 8 MonthsOutcome measures
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Target Vessel Myocardial Infarction (TVMI)
|
2 Participants
|
SECONDARY outcome
Timeframe: 8 MonthsOutcome measures
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Target Lesion Revascularization (TLR)
|
3 Participants
|
SECONDARY outcome
Timeframe: 8 MonthsDefined as death, myocardial infarction (Q wave and non-Q wave), emergent coronary bypass surgery, or clinically-driven repeat target lesion revascularization by percutaneous or surgical methods
Outcome measures
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Major Adverse Cardiac Event (MACE)
|
7 Participants
|
SECONDARY outcome
Timeframe: 8 MonthsOutcome measures
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Target Lesion Failure (TLF)
|
5 Participants
|
SECONDARY outcome
Timeframe: 8 MonthsOutcome measures
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Target Vessel Failure (TVF)
|
9 Participants
|
SECONDARY outcome
Timeframe: 8 MonthsOutcome measures
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Stent Thrombosis (ST)
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 MonthsOutcome measures
| Measure |
Device
n=75 Participants
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Cardiac Death and TVMI
|
2 Participants
|
Adverse Events
Device
Serious events: 27 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Device
n=75 participants at risk
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
2/75 • Number of events 2 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
4.0%
3/75 • Number of events 3 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Angina Pectoris
|
2.7%
2/75 • Number of events 2 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Angina Unstable
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Atrial Flutter
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Bradycardia
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Cardiac Failure Congestive
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Coronary Artery Disease
|
5.3%
4/75 • Number of events 4 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Coronary Artery Perforation
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Coronary Artery Stenosis
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Coronary Artery Thrombosis
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
In-Stent Coronary Artery Restenosis
|
2.7%
2/75 • Number of events 2 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Myocardial Infarction
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
2.7%
2/75 • Number of events 2 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Endocrine disorders
Thyroid Disorder
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
General disorders
Chest Pain
|
8.0%
6/75 • Number of events 8 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
General disorders
Puncture Site Haemorrhage
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Hepatobiliary disorders
Bile Duct Stone
|
1.3%
1/75 • Number of events 2 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Infections and infestations
Cellulitis
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Injury, poisoning and procedural complications
Fall
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Injury, poisoning and procedural complications
In-Stent Arterial Restenosis
|
4.0%
3/75 • Number of events 3 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Investigations
Cardiac Enzymes Increased
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Investigations
Liver Function Test Abnormal
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Neoplasm Of Thyroid Gland
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic Cancer Metastatic
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Neoplasm Malignant
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Surgical and medical procedures
Therapeutic Embolisation
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Vascular disorders
Hypotension
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Vascular disorders
Orthostatic Hypotension
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
2.7%
2/75 • Number of events 2 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Vascular disorders
Shock Haemorrhagic
|
1.3%
1/75 • Number of events 1 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
Other adverse events
| Measure |
Device
n=75 participants at risk
Medtronic Resolute Onyx Zotarolimus-Eluting Stent System
Resolute Onyx Stent - 2.25 mm - 4.0 mm
|
|---|---|
|
Cardiac disorders
Angina Pectoris
|
6.7%
5/75 • Number of events 5 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Cardiac disorders
Atrial Fibrillation
|
5.3%
4/75 • Number of events 4 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
5/75 • Number of events 7 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
General disorders
Chest Pain
|
16.0%
12/75 • Number of events 15 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
General disorders
Fatigue
|
5.3%
4/75 • Number of events 4 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
6.7%
5/75 • Number of events 5 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Investigations
Cardiac Enzymes Increased
|
9.3%
7/75 • Number of events 7 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
9.3%
7/75 • Number of events 7 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Nervous system disorders
Dizziness
|
6.7%
5/75 • Number of events 5 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.7%
14/75 • Number of events 16 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Vascular disorders
Hypertension
|
9.3%
7/75 • Number of events 7 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
|
Vascular disorders
Hypotension
|
5.3%
4/75 • Number of events 4 • All non-serious AEs are collected through the 12 month visit. All serious AEs are collected for the duration of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER