NCT05206084

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 518 (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-blinded, randomized trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease compared to the Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE).

Detailed description

IRONMAN-II is a prospective, multi-center, single-blinded, randomized trial to assess the safety and efficacy of the Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS) in treating patients with coronary artery disease compared to the Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System (XIENCE). A total of 518 subjects with coronary artery lesion(s) are intended to participate in this study. Angiographic follow-up will be required at 2 years, and an OCT subset including 50 subjects will undergo OCT follow-up. 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 late lumen loss at 2 years. The primary objective of this trial is to support the China pre-market approval of IBS Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System. IRONMAN-II will evaluate the safety and efficacy of the IBS in treating patients with coronary artery disease. The primary endpoint is late lumen loss at 2 years. The powered secondary objective is to evaluate long-term vascular function and patency of the IBS treated segments compared to XIENCE treated segments. The powered secondary endpoints include Quantitative Flow Ratio (QFR) and cross-section level mean flow area measured by OCT for OCT subset at 2 years. Data from the primary endpoint and two powered secondary endpoints will evaluate the non-inferiority of the IBS as compared to XIENCE.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Sirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS)	Subjects in this arm will be treated with IBS
DEVICE	Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System	Subjects in this arm will be treated with XIENCE

Timeline

• Start date: 2022-03-10
• Primary completion: 2024-12-29
• Completion: 2028-01-01
• First posted: 2022-01-25
• Last updated: 2025-12-10

Locations

1 site across 1 country: China