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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,059
Subjects in this arm will be treated with IBS
Fuwai Yunnan Cardiovascular Hospital
Kunming, Yunnan, China
Rate of target lesion failure
Target Lesion Failure (TLF), defined as the composited endpoints of cardiac death/Target Vessel Myocardial Infarction (TV-MI)/Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 1 year
Rate of Device Success
Device Success is defined as: A visually estimated diameter stenosis of \< 30% after implantation of the device and TIMI flow of III.
Time frame: Immediately post-procedure
Rate of Lesion Success
Lesion Success is defined as: The attainment of visual residual stenosis \< 30% and TIMI flow of III after any intervention in target lesion.
Time frame: Immediately post-procedure
Rate of Clinical Success
Clinical Success is defined as: lesion success, AND there is no major adverse cardiac events in the hospitalization period.
Time frame: ≤ 7 days post the index procedure (In-hospital)
Rate of Device-oriented Composite Endpoint (DoCE)
Target Lesion Failure (TLF), defined as the composited endpoints of cardiac death/Target Vessel Myocardial Infarction (TV-MI)/Ischemic-Driven Target Lesion Revascularization (ID-TLR).
Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Rate of Patient-oriented Composite Endpoint (PoCE)
Including all-cause mortality, any myocardial infarction and any revascularization.
Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Rate of Death (Cardiac, Vascular and Non-cardiovascular)
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Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Rate of Myocardial infarction (Attributable to target vessel (TV-MI), or Not attributable to target vessel (NTV-MI))
Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Rate of Target Lesion Revascularization (Ischemia driven, or not ischemia driven)
Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Rate of Target Vessel Revascularization (Ischemia driven, or not ischemia driven)
Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Rate of all coronary revascularization
Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Rate of Stent Thrombosis defined by ARC (definite and probable)
Stent thrombosis is defined by Academic Research Consortium (ARC) criteria as definite, probable, and possible. Stent thrombosis was categorized as acute, subacute, late, and very late.
Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years