The purpose of this study is to assess the safety and effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive, non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,684
A drug eluting coronary stent system
A drug eluting coronary stent system
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Time frame: 12 months
Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.
The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) \& TLR Coronary Artery Bypass Graft (CABG).
Time frame: 12 months
Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.
TVR overall includes: TVR PCI \& TVR CABG.
Time frame: 12 months
Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.
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
Percentage of Participants With Myocardial Infarction at 12 Month.
The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.
Time frame: 12 months
Percentage of Participants With Cardiac Death at 12 Month.
Time frame: 12 months
Percentage of Participants With Non-Cardiac Death at 12 Month.
Time frame: 12 months
Percentage of Patients That Died at 12 Months.
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Baptist Medical Center - Princeton
Birmingham, Alabama, United States
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Bakersfield Memorial Hospital
Bakersfield, California, United States
University of California Davis Health System
Sacramento, California, United States
Sutter Memorial Hospital
Sacramento, California, United States
Alvarado Hospital Medical Center
San Diego, California, United States
North Colorado Medical Center
Greeley, Colorado, United States
South Denver Cardiology Associates, PC
Littleton, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
...and 116 more locations
The Death rate includes Cardiac- \& Non-Cardiac Death.
Time frame: 12 months
Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.
Time frame: 12 months
Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.
Time frame: 12 months
Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.
Time frame: 12 months
Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.
Time frame: 12 months
Percentage of Patients With a Stroke at 12 Month.
The stroke rate includes: Ischemic- , Hemorraghic- \& Undetermined Stroke.
Time frame: 12 months
Periprocedural Technical Success Rate.
Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.
Time frame: Day 1 (periprocedure)
Periprocedural Clinical Procedural Success Rate
Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.
Time frame: Day 1 (periprocedure)
Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.
Time frame: 12 month
Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.
All CEC adjudicated revascularization at 12 month (Intent to treat population).
Time frame: 12 Month