EVOLVE II Clinical Trial
EVOLVE II Clinical Trial 12 Month Primary Outcomes
SYNERGY™ Stent demonstrated exceptional outcomes in the EVOLVE II Clinical Trial, the first successful U.S. Pivotal Trial of a bioabsorbable polymer technology.
The SYNERGY stent is an investigational device and not available for sale in the U.S. or Japan.
EVOLVE II Clinical Trial Baseline Characteristics for the SYNERGY Stent Arm
EVOLVE II Clinical Trial Study Overview:
Patients with ≤3 native coronary artery lesions in ≤2 major epicardial vessels; lesion length ≤34 mm, RVD ≥2.25 mm ≤4.0, %DS> 50 <100 (excluded LM disease, SVG, CTO, or recent STEMI)
Most complex patient population ever studied in a U.S. Pivotal Trial
12 Month Stent Thrombosis (ST) Rates
Zero Definite ST Events in SYNERGY Stent Arm after 24 Hours
* ST Event occurred on day 6
Outstanding Clinical Outcomes in a Complex Patient Population
Primary Endpoint of Target Lesion Failure1 (TLF) Met in both Intent to Treat and in Per Protocol Patient Populations
