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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
A drug eluting coronary stent system
University of Alabama at Birmingham
Birmingham, Alabama, United States
HealthEast St. Joseph's Hospital
Saint Paul, Minnesota, United States
New York Presbyterian Hospital - Columbia University Medical Center
Target Lesion Failure Rate at 12-months
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.
Time frame: 12-month
Target Lesion Revascularization (TLR) Rate at 12 Months
The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) and TLR Coronary Artery Bypass Graft (CABG)
Time frame: 12 months
Target Vessel Revascularization (TVR) Rate at 12 Months.
TVR overall includes: TVR PCI and TVR CABG
Time frame: 12 months
Target Vessel Failure (TVF) Rate at 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.
Time frame: 12 months
MI (Q-wave and Non-Q-wave) Rate
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.
Time frame: 12 months
Cardiac Death Rate
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.
Time frame: 12 months
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New York, New York, United States
Rex Hospital
Raleigh, North Carolina, United States
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, United States
York Hospital
York, Pennsylvania, United States
Baylor Heart & Vascular Hospital
Dallas, Texas, United States
The Heart Hospital Baylor Plano
Plano, Texas, United States
P. Stradins University Hospital
Riga, Latvia
Auckland City Hospital
Auckland, New Zealand
...and 5 more locations
Non-cardiac Death Rate
Non-cardiac death is defined as a death not due to cardiac causes as previously defined.
Time frame: 12 months
All Death Rate
Time frame: 12 months
Cardiac Death or MI Rate
Time frame: 12 months
All Death or MI Rate
Time frame: 12 months
All Death/MI/TVR Rate
Time frame: 12 months
Stent Thrombosis Rate
Time frame: 12 months
Periprocedural Technical Success Rate
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.
Time frame: Day 1 (periprocedural)
Periprocedural Clinical Procedural Success Rate
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.
Time frame: 12 months