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A Clinical Trial to Evaluate the Safety and Efficacy of IBS in Patients With Coronary Artery Disease — IRONMAN-III  

Coronary Artery Disease Clinical Trial

Official title:
A Prospective, Multi-Center, Single-arm Trial of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System in Patients With Coronary Artery Disease: IRONMAN-III

Clinical Trial Summary

A prospective, multi-center, single-arm trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease.

Clinical Trial Description

IRONMAN-III is a prospective, multi-center, single-arm trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease. A total of 1059 subjects (including subjects in IRONMAN-II randomized control trial) with coronary artery lesion(s) are intended to participate in this study. Clinical follow-up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. The primary endpoint is the rate of target lesion failure at 1 year. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05205499
Study type Interventional
Source Biotyx Medical (Shenzhen) Co., Ltd.
Contact
Status Active, not recruiting
Phase N/A
Start date March 10, 2022
Completion date August 2028
View Details
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