Coronary Artery Disease Clinical Trial
Official title:
A Randomized Controlled Trial of the Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in Patients With Coronary Artery Disease: BIOHEART-II
The Bioheart Randomized Controlled Trial is a prospective multicentred paralleled study, which will enroll 430 patients and randomized 1:1 to study group and control group. Aim to assess the efficacy and safety of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System compare with XIENCE stent in the treatment of patients with up to two coronary lesions.
This study is a prospective, multicentred randomized controlled trial, planning to enroll 430
subjects and randomize 1:1 to study group and control group.
All subjects will accept clinical evaluation at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5
year post procedure.
All subjects will accept angiographic evaluation at 1 year post procedure, and simutaneously
80 subjects (40 in study group and 40 in control group) will accepted OCT evaluation.
To assess the efficacy and safety, the primary endpoint will be in segment late luminal loss
at 1 year post procedure, the secondary endpoint is neointima coverage percentage of stent
strut (%) at 1 year post procedure.
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