Single Coronary Vessel Disease Clinical Trial
Official title:
A Prospective, Non-randomized, Open-label, Non-comparative, First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
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, non-randomized trial
- Study population: 15 patients
- Clinical follow up will be required at postoperative, 1 month, 6 months, 1 year, 2
years, 3 years, 4 years, 5 years;
- All the subjects perform the angiography, Intra-vascular ultrasound (IVUS) and Optical
coherence tomography (OCT) at 1 year and 3 years.
- The primary study endpoint is target lesion failure (TLF) at 1 month post procedure; and
imaging findings as the secondary study endpoint. To evaluate the feasibility, safety
and performance of IBS.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT03509142 -
A First-in-Man Study of IBS
|
N/A |