Coronary Artery Disease Clinical Trial
Official title:
A Randomized Trial of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients With Coronary Artery Disease: FUTURE-II
The FUTURE-II study is a confirmative clinical trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has been preliminary confirmed in a small-scale First-in-Man clinical trial.
This study is a prospective, multicenter, single-blind, randomized controlled trial in patients with coronary artery disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels. The goal is to evaluate the safety and effectiveness of Firesorb to support the approval of the Chinese Food and Drug Administration (CFDA) for this product. The Abbott's XIENCE Everolimus-eluting Coronary Stent System is selected as the control device. 430 subjects will be recruited. All subjects will be 1:1 randomly assigned to experimental group and control group. All subjects will undergo clinical follow-up at 1-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-index procedure. All subjects will undergo angiographic follow-up at 1-year post-index procedure; of which 3-5 centers will be specified as a subgroup to complete OCT follow-up (n=80, 40 each in test and control group). ;
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