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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
518
Subjects in this arm will be treated with IBS
Subjects in this arm will be treated with XIENCE
Fuwai Yunnan Cardiovascular Hospital
Kunming, China
In-segment Late lumen loss (LLL)
Time frame: 2 years
Powered Secondary Endpoint: Quantitative Flow Ratio (QFR)
Time frame: 2 years
Powered Secondary Endpoint: Cross-section level mean flow area measured by OCT
Only for subjects in OCT subset
Time frame: 2 years
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 event 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.
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Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Rate of Death (Cardiac, Vascular and Non-cardiovascular)
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, very late.
Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years
Acute recoil
Time frame: Immediately post-procedure
Minimal lumen diameter (MLD) (In-stent, in-segment, proximal 5mm and distal 5mm MLD)
Time frame: at post-procedure, 2 years
Diameter stenosis (DS %) (In-device, in-segment, proximal 5mm and distal 5mm DS%)
Time frame: at post-procedure, 2 years
Late Lumen Loss (LLL) (In-device, proximal 5mm and distal 5mm LLL)
Time frame: 2 years
Angiographic binary restenosis (ABR) (In-device, in-segment, proximal 5mm and distal 5mm ABR)
Time frame: 2 years
Thickness of neointima (struts level)
Time frame: 2 years
Minimal lumen area
Time frame: 2 years
Percentage of neointima-covered struts
Time frame: 2 years
Late incomplete strut apposition
Time frame: 2 years
Lumen area stenosis %
Time frame: 2 years
Healing score
Healing score = (presence of intra-scaffold structure \* 4) + (presence of both malapposed and uncovered struts \* 3) + (presence of uncovered struts alone \* 2) + (presence of malapposition alone \* 1).
Time frame: 2 years
Stent Absorption (%)
Time frame: 2 years
Late recoil area
Time frame: 2 years
Late recoil proportion
Time frame: 2 years