NCT03509142

A First-in-Man Study of IBS

A Prospective, Single-Center, First-in-Man Trial of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in Patients With Coronary Artery Disease: IRONMAN-I

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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: 1. Target lesion failure (TLF) at 6 months post procedure 2. Late Lumen Loss at 6 months post procedure

Conditions

• Single Coronary Vessel Disease

Interventions

Type	Name	Description
DEVICE	Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System	Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)

Timeline

• Start date: 2018-04-10
• Primary completion: 2019-07-19
• Completion: 2023-12-10
• First posted: 2018-04-26
• Last updated: 2025-04-25

Locations

1 site across 1 country: China