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The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System(IBS). The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS. To provide the basis for subsequent large-scale, multi-center, randomized controlled clinical trials of IBS.
Full description
A prospective, single-center, First-in-Man trial;
Study population: 45 subjects.
45 subjects will be randomly assigned into two cohorts: cohort 1(n=30), cohort 2(n=15)
The clinical follow up will be performed in all subjects at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years post procedure;
The Angiographic, Intra-Vascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) will be performed at 6 months and 2 years post procedure in cohort 1. The Angiographic, IVUS and OCT will be performed at 1 year and 3 years post procedure in cohort 2.
The primary study endpoints:
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Inclusion criteria
All patients participating in this clinical trial must meet the following criteria:
Exclusion criteria
Patients will be excluded if any of the following conditions apply:
General:
Exclusion criteria by angiography:
A.DS% < 40% (visual), highly recommend DS% ≤20% B.TIMI blood flow= class 3 (visual) C.No angiography complications (e.g., distal embolization, lateral branch closed) D.No interlining level NHLBI type D - F E.No continuous chest pain (> 5 minutes), and F.No lower or higher ST segment >5 minutes.
Primary purpose
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Interventional model
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45 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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