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.
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).