NCT05205499

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,059 (actual)
• Sponsor: Biotyx Medical (Shenzhen) Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System	Subjects in this arm will be treated with IBS

Timeline

• Start date: 2022-03-10
• Primary completion: 2024-07-01
• Completion: 2028-08-01
• First posted: 2022-01-25
• Last updated: 2025-12-10

Locations

1 site across 1 country: China