Trial Outcomes & Findings for RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort) (NCT NCT03584464)
NCT ID: NCT03584464
Last Updated: 2023-11-24
Results Overview
Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
205 participants
Primary outcome timeframe
12 Months
Results posted on
2023-11-24
Participant Flow
Participant milestones
| Measure |
Bifurcation Cohort
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Overall Study
STARTED
|
205
|
|
Overall Study
COMPLETED
|
204
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Subjects did not provide this information
Baseline characteristics by cohort
| Measure |
Bifurcation Cohort
n=205 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 5.0 mm in diameter for the treatment of a bifurcation lesion with provisional stenting.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=205 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
87 Participants
n=205 Participants
|
|
Age, Categorical
>=65 years
|
118 Participants
n=205 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=205 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=205 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=194 Participants • Subjects did not provide this information
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
182 Participants
n=194 Participants • Subjects did not provide this information
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=194 Participants • Subjects did not provide this information
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=193 Participants • Subjects did not provide this information
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=193 Participants • Subjects did not provide this information
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=193 Participants • Subjects did not provide this information
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=193 Participants • Subjects did not provide this information
|
|
Race (NIH/OMB)
White
|
159 Participants
n=193 Participants • Subjects did not provide this information
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=193 Participants • Subjects did not provide this information
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants • Subjects did not provide this information
|
|
Region of Enrollment
United States
|
167 Participants
n=205 Participants
|
|
Region of Enrollment
Europe
|
38 Participants
n=205 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsTarget Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
Outcome measures
| Measure |
Bifurcation Cohort
n=204 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Number of Participants With Target Vessel Failure (TVF)
|
14 Participants
|
SECONDARY outcome
Timeframe: 12 monthsCardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.
Outcome measures
| Measure |
Bifurcation Cohort
n=204 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Number of Participants With Cardiac Death
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 12 monthsTarget Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
Outcome measures
| Measure |
Bifurcation Cohort
n=204 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI)
|
6 Participants
|
SECONDARY outcome
Timeframe: 12 monthsTarget Lesion Revascularization (TLR) defined as repeat PCI (Percutaneous Coronary Intervention), CABG (Coronary Artery Bypass Surgery) to the target lesion, or clinically driven target lesion revascularization.
Outcome measures
| Measure |
Bifurcation Cohort
n=204 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Number of Participants With Target Lesion Revascularization (TLR)
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 monthsTarget Vessel Revascularization (TVR) defined as revascularization of the target vessel.
Outcome measures
| Measure |
Bifurcation Cohort
n=204 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Number of Participants With Target Vessel Revascularization (TVR)
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 monthsCardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
Outcome measures
| Measure |
Bifurcation Cohort
n=204 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Number of Participants With Cardiac Death and TVMI
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 monthsMajor Adverse Cardiac Event (MACE) defined 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 |
Bifurcation Cohort
n=204 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Number of Participants With Major Adverse Cardiac Event (MACE)
|
17 Participants
|
SECONDARY outcome
Timeframe: 12 monthsTarget Lesion Failure (TLF) defined as cardiac death, target vessel myocardial infarction (Q wave and non-Q wave), or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods.
Outcome measures
| Measure |
Bifurcation Cohort
n=204 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Number of Participants With Target Lesion Failure (TLF)
|
13 Participants
|
SECONDARY outcome
Timeframe: 12 monthsStent Thrombosis Definite/Probable defined per Academic Research Consortium (ARC). Definite: a. Angiographic confirmation of TIMI flow grade 0-3 and at least one of the following criteria within a 48 hour: 1.New onset s ischemic symptoms at rest (typical chest pain with duration \>20 minutes); 2.New ischemic ECG changes suggestive of acute ischemia; 3.Typical rise and fall in cardiac biomarkers. or b. Pathologic confirmation of stent thrombosis: Evidence of recent thrombus within the stent determined at autopsy or via examination of tissue retrieved following thrombectomy. Probable: Any unexplained death within the first 30 days.
Outcome measures
| Measure |
Bifurcation Cohort
n=204 Participants
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Number of Participants With Stent Thrombosis (ARC) Definite/Probable
|
0 Participants
|
Adverse Events
Bifurcation Cohort
Serious events: 48 serious events
Other events: 39 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Bifurcation Cohort
n=205 participants at risk
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Blood and lymphatic system disorders
Normocytic Anaemia
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Acute Left Ventricular Failure
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.0%
4/205 • Number of events 4 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
2.0%
4/205 • Number of events 4 • 12 months
|
|
Cardiac disorders
Angina Unstable
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Atrial Fibrillation
|
0.98%
2/205 • Number of events 2 • 12 months
|
|
Cardiac disorders
Atrioventricular Block Second Degree
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Cardiac Arrest
|
0.98%
2/205 • Number of events 2 • 12 months
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.98%
2/205 • Number of events 3 • 12 months
|
|
Cardiac disorders
Coronary Artery Disease
|
2.0%
4/205 • Number of events 4 • 12 months
|
|
Cardiac disorders
Coronary Artery Dissection
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Sinus Arrest
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.49%
1/205 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Melaena
|
0.49%
1/205 • Number of events 2 • 12 months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
General disorders
Chest Pain
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
General disorders
Death
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
General disorders
Non-Cardiac Chest Pain
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
General disorders
Vascular Stent Stenosis
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
General disorders
Vessel Puncture Site Haematoma
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Immune system disorders
Drug Hypersensitivity
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Infections and infestations
Cellulitis
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Infections and infestations
Covid-19
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Infections and infestations
Gastroenteritis Viral
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Infections and infestations
Influenza
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Infections and infestations
Localised Infection
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Infections and infestations
Pneumonia
|
1.5%
3/205 • Number of events 3 • 12 months
|
|
Infections and infestations
Sepsis
|
0.98%
2/205 • Number of events 2 • 12 months
|
|
Infections and infestations
Septic Shock
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Cardiac Procedure Complication
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Postoperative Respiratory Failure
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Investigations
Myocardial Necrosis Marker Increased
|
1.5%
3/205 • Number of events 3 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder Cancer
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.98%
2/205 • Number of events 2 • 12 months
|
|
Nervous system disorders
Dizziness
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Nervous system disorders
Paraesthesia
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Nervous system disorders
Unresponsive To Stimuli
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.49%
1/205 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.98%
2/205 • Number of events 2 • 12 months
|
|
Surgical and medical procedures
Carotid Endarterectomy
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Surgical and medical procedures
Coronary Artery Bypass
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Vascular disorders
Haematoma
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Vascular disorders
Hypotension
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Vascular disorders
Peripheral Arterial Occlusive Disease
|
0.49%
1/205 • Number of events 1 • 12 months
|
Other adverse events
| Measure |
Bifurcation Cohort
n=205 participants at risk
Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System: Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.98%
2/205 • Number of events 2 • 12 months
|
|
Blood and lymphatic system disorders
Blood Loss Anaemia
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Angina Pectoris
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Bradycardia
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Bundle Branch Block Left
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Coronary Artery Disease
|
1.5%
3/205 • Number of events 3 • 12 months
|
|
Cardiac disorders
Coronary Artery Dissection
|
0.98%
2/205 • Number of events 2 • 12 months
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
General disorders
Chest Discomfort
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
General disorders
Chest Pain
|
0.98%
2/205 • Number of events 2 • 12 months
|
|
General disorders
Injection Site Haemorrhage
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
General disorders
Malaise
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
General disorders
Vascular Stent Stenosis
|
0.98%
2/205 • Number of events 2 • 12 months
|
|
Infections and infestations
Urinary Tract Infection
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Cardiac Procedure Complication
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Face Injury
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Patella Fracture
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Periprocedural Myocardial Infarction
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Plaque Shift
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Vascular Access Complication
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Injury, poisoning and procedural complications
Vascular Access Site Swelling
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Investigations
Inflammatory Marker Increased
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Investigations
Myocardial Necrosis Marker Increased
|
3.4%
7/205 • Number of events 7 • 12 months
|
|
Investigations
Troponin I Increased
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Investigations
Troponin Increased
|
1.5%
3/205 • Number of events 3 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal Proliferative Breast Lesion
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Nervous system disorders
Headache
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Nervous system disorders
Paraesthesia
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Nervous system disorders
Seizure
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Renal and urinary disorders
Urinary Retention
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.49%
1/205 • Number of events 1 • 12 months
|
|
Vascular disorders
Labile Hypertension
|
0.49%
1/205 • Number of events 1 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER