Single Coronary Vessel Disease Clinical Trial
Official title:
A First-in-Man Study of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)
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.
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: 1. Target lesion failure (TLF) at 6 months post procedure 2. Late Lumen Loss at 6 months post procedure ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03616132 -
A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
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N/A |