Acute Coronary Syndrome Clinical Trial
Official title:
A Prospective, Multi-Center, Open Label, Randomized Controlled, Two Arm Study Evaluating Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent Resolute Integrity Compared to the Polymer Free Amphilimus Eluting Stent Cre8
The study objective is to assess the safety and efficacy of the Permanent Polymer Zotarolimus-Eluting Stent Resolute Integrity™ to the Polymer Free Amphilimus-Eluting Stent Cre8™ compared in an all-comer patient population. 1 month of dual antiplatelet duration will be applied in stable angina pectoris patients. Myocardial infarction patient population will be treated with 12 months of dual antiplatelet therapy.
A Prospective, Multi-Center, Open Label, Randomized Controlled, two-arm Study to Evaluate the
Safety and Efficacy of the Permanent Polymer Zotarolimus Eluting Stent 'Resolute Integrity™'
Compared to Polymer Free Amphilimus Eluting Stent 'Cre8'. Dual Antiplatelet Therapy duration
of 1 Month will be applied in stable angina pectoris patient population. Myocardial
infarction patient population will be treated with 12 months of dual antiplatelet therapy
(DAPT).
One thousand five hundred thirty-two (1532) patients (1:1 randomization Cre8 stent: Resolute
Integrity™ stent) will be enrolled in the study, with clinical follow-up at 12 months to
assess the primary end point.
After a period of 12 months, a clinical registry will be implemented Information will be
collected at 3-years post procedure.
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