EVOLVE 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the SYNERGY 4.50 mm and 5.00 mm Coronary Stent System for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries \> 4.00 mm to ≤5.00 mm in diameter, by visual estimate). This Post Approval study is a cohort associated with the SYNERGY MEGATRON Post Approval Study, which is registered under ClinicalTrials.gov ID: NCT04807439.
Study Type
OBSERVATIONAL
Enrollment
100
The SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System), manufactured by BSC, is a device/drug combination product comprised of two regulated components: a device (Coronary Stent System) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
Yale New Haven Hospital
New Haven, Connecticut, United States
Clearwater Cardiovascular Consultants
Clearwater, Florida, United States
Beth Israel Deaconness Medical Center
Boston, Massachusetts, United States
North Kansas City Hospital
Kansas City, Missouri, United States
Wake Medical Center
Raleigh, North Carolina, United States
Lindner Center for Research and Education at Christ Hospital
Cincinnati, Ohio, United States
Oregon Health Science University
Portland, Oregon, United States
Baylor Heart and Vascular Hospital
Dallas, Texas, United States
Inova Fairfax Hospital
Fairfax, Virginia, United States
Target Lesion Failure (TLF) rate
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-months
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