RESOLUTE ONYX Post-Approval Study (Bifurcation Cohort)
- Conditions
- Coronary Artery Disease
- Interventions
- Device: Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System
- Registration Number
- NCT03584464
- Lead Sponsor
- Medtronic Vascular
- Brief Summary
To observe the continued performance of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in a real-world more-comer population.
To collect data on the safety and efficacy of the Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System in bifurcated lesions.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 205
Not provided
- Unprotected left main disease
- Subjects with planned PCI of three vessel disease
- Planned two stent technique (main branch and side branch) of a bifurcation
- Subjects with more than one bifurcation lesion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Bifurcation Cohort Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System Subjects receiving stents 2.0 mm - 5.0 mm in diameter will be included in the Bifurcation Cohort.
- Primary Outcome Measures
Name Time Method Number of Participants With Target Vessel Failure (TVF) 12 Months Target Vessel Failure (TVF) defined as cardiac death, target vessel myocardial infarction, or clinically-driven target vessel revascularization by percutaneous or surgical methods.
- Secondary Outcome Measures
Name Time Method Number of Participants With Target Vessel Revascularization (TVR) 12 months Target Vessel Revascularization (TVR) defined as revascularization of the target vessel.
Number of Participants With Cardiac Death 12 months Cardiac Death defined as any death due to immediate cardiac cause, unwitnessed death and death of unknown cause.
Number of Participants With Target Vessel Myocardial Infarction (TVMI - 3rd UDMI) Up to 12 months Target Vessel Myocardial Infarction (TVMI) defined as myocardial infarction with the target vessel. (3rd UDMI)
Number of Participants With Target Lesion Revascularization (TLR) 12 months Target 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.
Number of Participants With Target Lesion Failure (TLF) 12 months Target 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.
Number of Participants With Cardiac Death and TVMI 12 months Cardiac Death and TVMI defined as composite of cardiac death and target vessel myocardial infarction.
Number of Participants With Major Adverse Cardiac Event (MACE) 12 months Major 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.
Number of Participants With Stent Thrombosis (ARC) Definite/Probable 12 months Stent 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.
Trial Locations
- Locations (25)
Scripps Green Hospital
🇺🇸La Jolla, California, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Desert Springs Hospital
🇺🇸Las Vegas, Nevada, United States
Baptist Memorial Hospital-Memphis
🇺🇸Germantown, Tennessee, United States
CHU Toulouse - Hôpital Rangueil
🇫🇷Toulouse, France
WellStar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Tallahassee Memorial Hospital
🇺🇸Tallahassee, Florida, United States
St. Josephs Hospital Health Center
🇺🇸East Syracuse, New York, United States
NYU Langone Medical Center
🇺🇸New York, New York, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
New York-Presbyterian Hospital/ Columbia University Medical Center
🇺🇸New York, New York, United States
Abbott Northwestern
🇺🇸Minneapolis, Minnesota, United States
University of Virginia Medical Center
🇺🇸Charlottesville, Virginia, United States
CHU Charleroi
🇧🇪Charleroi, Belgium
Ziekenhuis Oost Limburg
🇧🇪Genk, Belgium
Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Riverside Community Hospital
🇺🇸Riverside, California, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
Huntsville Hospital
🇺🇸Huntsville, Alabama, United States
Morton Plant Hospital
🇺🇸Clearwater, Florida, United States
Stredoslovensky Ustav Srdcovych a Cievnych Chorob a.s
🇸🇰Banska Bystrica, Slovakia
North Florida Regional Medical Center
🇺🇸Gainesville, Florida, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States