A Clinical Trial to Assess the SYNERGY 48 mm Stent System for the Treatment of Atherosclerotic Lesion(s)
- Conditions
- Coronary Artery Disease
- Interventions
- Device: SYNERGY 48 mm
- Registration Number
- NCT03350542
- Lead Sponsor
- Boston Scientific Corporation
- Brief Summary
EVOLVE 48 is a prospective, open label, single arm, multi-center trial. The purpose of this study is to assess the FDA requirement for safety and effectiveness of the SYNERGY 48 mm Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) \> 34 mm and ≤ 44 mm in length (by visual estimate) in native coronary arteries ≥2.5 mm to ≤4.0 mm in diameter (by visual estimate).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SYNERGY 48 mm SYNERGY 48 mm SYNERGY 48 mm is a device/ drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating)
- Primary Outcome Measures
Name Time Method Target Lesion Failure Rate at 12-months 12-month The primary endpoint is the 12-month Target Lesion Failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
- Secondary Outcome Measures
Name Time Method All Death Rate 12 months All Death or MI Rate 12 months Periprocedural Technical Success Rate Day 1 (periprocedural) Successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% in 2 near-orthogonal projections with Thrombolysis in Myocardial Infarction (TIMI) 3 flow in the target lesion, as visually assessed by the physician.
Cardiac Death or MI Rate 12 months Target Lesion Revascularization (TLR) Rate at 12 Months 12 months The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) and TLR Coronary Artery Bypass Graft (CABG)
Target Vessel Revascularization (TVR) Rate at 12 Months. 12 months TVR overall includes: TVR PCI and TVR CABG
Target Vessel Failure (TVF) Rate at 12 Months 12 months Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.
MI (Q-wave and Non-Q-wave) Rate 12 months The MI rate includes: MIs related to the Target Vessel, MIs with unknown relationship to the Target Vessel and MIs not related to the Target Vessel.
Cardiac Death Rate 12 months Cardiac death is defined as death due to any of the following; acute MI, cardiac perforation/pericardial tamponade, arrhythmia or conduction abnormality, CVA through hospital discharge or CVA suspected of being related to the procedure, death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery and any death in which a cardiac cause cannot be excluded.
Non-cardiac Death Rate 12 months Non-cardiac death is defined as a death not due to cardiac causes as previously defined.
All Death/MI/TVR Rate 12 months Stent Thrombosis Rate 12 months Periprocedural Clinical Procedural Success Rate 12 months Post-procedure lesion diameter stenosis \<30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician, without the occurrence of in-hospital cardiac death, MI, or TVR.
Trial Locations
- Locations (15)
HealthEast St. Joseph's Hospital
🇺🇸Saint Paul, Minnesota, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
P. Stradins University Hospital
🇱🇻Riga, Latvia
Rex Hospital
🇺🇸Raleigh, North Carolina, United States
Baylor Heart & Vascular Hospital
🇺🇸Dallas, Texas, United States
The Heart Hospital Baylor Plano
🇺🇸Plano, Texas, United States
Freeman Hospital
🇬🇧Newcastle Upon Tyne, United Kingdom
New York Presbyterian Hospital - Columbia University Medical Center
🇺🇸New York, New York, United States
Lindner Center for Research and Education at Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Auckland City Hospital
🇳🇿Auckland, New Zealand
North Shore Hospital
🇳🇿Takapuna, New Zealand
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
Golden Jubilee National Hospital
🇬🇧Glasgow, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
York Hospital
🇺🇸York, Pennsylvania, United States