A First-in-Man Study to Evaluate the Feasibility and Safety of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System

  • End date
    Mar 30, 2023
  • participants needed
  • sponsor
    Lifetech Scientific (Shenzhen) Co., Ltd.
Updated on 12 February 2022


The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold SystemIBS. 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.

Condition Single Coronary Vessel Disease
Treatment Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System
Clinical Study IdentifierNCT03616132
SponsorLifetech Scientific (Shenzhen) Co., Ltd.
Last Modified on12 February 2022


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