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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Biotyx Medical (Shenzhen) Co., Ltd.
- Enrollment
- 518
- Locations
- 1
- Primary Endpoint
- In-segment Late lumen loss (LLL)
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patient must between 18 and 75 years old, male or non-pregnant female.
- •Patient must have evidence of myocardial ischemia (e.g., stable, unstable angina, silent myocardial ischemia, or acute myocardial infarction\>1 week) suitable for elective PCI.
- •One or two de novo target lesions each located in a different epicardial vessel.
- •If there is one target lesion, another non-target lesion may be treated but the non-target lesion must be present in a different epicardial vessel, and must be treated first with a successful result prior to randomization of the target lesion.
- •If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria.
- •The definition of epicardial vessels means the left anterior descending artery (LAD), the left circumflex artery (LCX), and the right coronary artery (RCA) and their branches. Thus, for example, the subject must not have lesions requiring treatment in both the LAD and a diagonal branch.
- •Lesion(s) must have a visually estimated length of ≤33mm, diameter between range of 2.5-4.0mm, and each lesion can be completely covered by a stent.
- •Lesion(s) must have a visually estimated diameter stenosis of ≥70% (or ≥50% and have evidence of myocardial ischemia in this location) with a TIMI flow of ≥
- •Patient can understand the study purpose, voluntarily participate in the study, sign the informed consent, and willing to undergo protocol-required invasive angiographic follow-ups.
Exclusion Criteria
- •General Exclusion Criteria
- •Patient had an acute myocardial infarction (AMI) or CK and CK-MB have not returned to within normal limits after myocardial infarction within 7 days of the index procedure.
- •Patient has implanted stent in the target vessel within 1 year of the index procedure, or is scheduled to undergo re-intervention in the future 6 months.
- •Patient with a history of coronary artery bypass (coronary artery bypass grafting).
- •Patient with contraindications on coronary artery bypass graft surgery.
- •Patient with severe heart failure (NYHA class ≥III) or left ventricular ejection fraction\<40% (by echocardiography or contrast left ventriculography).
- •Patient with known renal insufficiency: serum creatinine \> 2.0 mg/dl or 177 μmol/L, or/and patient on dialysis.
- •Patient with known hepatic insufficiency: ALT, AST \>3 times the upper limit of normal.
- •Patient had an ischemic stroke within 6 months or transient ischemic neurological attack (TIA) within 3 months before the index procedure, or has tendency of hypercoagulation as per investigator judgement or laboratory test.
- •Patient with bleeding diathesis, active gastrointestinal ulcers, history of cerebral hemorrhage or subarachnoid hemorrhage, contraindications on antiplatelet agents and anticoagulant therapy, and unable to undergoing antithrombotic therapy.
Outcomes
Primary Outcomes
In-segment Late lumen loss (LLL)
Time Frame: 2 years
Secondary Outcomes
- Powered Secondary Endpoint: Quantitative Flow Ratio (QFR)(2 years)
- Rate of Device-oriented Composite Endpoint (DoCE)(1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years)
- Rate of Death (Cardiac, Vascular and Non-cardiovascular)(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)(1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years)
- Rate of Stent Thrombosis defined by ARC (definite and probable)(1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years)
- Acute recoil(Immediately post-procedure)
- Angiographic binary restenosis (ABR) (In-device, in-segment, proximal 5mm and distal 5mm ABR)(2 years)
- Late incomplete strut apposition(2 years)
- Powered Secondary Endpoint: Cross-section level mean flow area measured by OCT(2 years)
- Rate of Device Success(Immediately post-procedure)
- Rate of Lesion Success(Immediately post-procedure)
- Rate of Clinical Success(≤ 7 days post the index procedure (In-hospital ))
- Rate of Patient-oriented Composite Endpoint (PoCE)(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))(1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years)
- Minimal lumen diameter (MLD) (In-stent, in-segment, proximal 5mm and distal 5mm MLD)(at post-procedure, 2 years)
- Diameter stenosis (DS %) (In-device, in-segment, proximal 5mm and distal 5mm DS%)(at post-procedure, 2 years)
- Late Lumen Loss (LLL) (In-device, proximal 5mm and distal 5mm LLL)(2 years)
- Percentage of neointima-covered struts(2 years)
- Lumen area stenosis %(2 years)
- Stent Absorption (%)(2 years)
- Rate of Target Vessel Revascularization (Ischemia driven, or not ischemia driven)(1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years)
- Rate of all coronary revascularization(1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years)
- Thickness of neointima (struts level)(2 years)
- Minimal lumen area(2 years)
- Healing score(2 years)
- Late recoil area(2 years)
- Late recoil proportion(2 years)