Clinical Trial

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

Study acronym: IRONMAN-II
Active, Not Recruiting
View on ClinicalTrials.gov →
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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-01-11; most recent amendment 2025-12-04.
Status change: Recruiting → Active, Not Recruiting 2022-12-13
Status change: Not Yet Recruiting → Recruiting 2022-03-16
Trial Details
NCT Number NCT05206084
Lead Sponsor Biotyx Medical (Shenzhen) Co., Ltd.
Conditions Coronary Artery Disease
Enrollment 518 participants
Start Date 2022-03-10
Primary Completion 2024-12-29 (estimated)
Study Completion 2028-01 (estimated)
Updated on ClinicalTrials.gov 2025-12-10