Last updated on February 2018

BioheartRapamycin Drug-Eluting Bioresorbable Coronary Stent System Clinical Study


Brief description of study

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 compare the efficacy and safety of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System to XIENCE stent in the treatment of patients with up to two coronary lesions.

Detailed Study Description

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 accepte clinical evaluation at 1 month, 6 month, 9 month and 1, 2, 3, 4, 5 year post procedure.

All subjects will accepte 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.

Clinical Study Identifier: NCT03284255

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Recruitment Status: Open


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