Coronary Artery Disease
Conditions
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.
Interventions
DEVICESirolimus-Eluting Iron Bioresorbable Coronary Scaffold System (IBS)
Subjects in this arm will be treated with IBS
Subjects in this arm will be treated with XIENCE
Sponsors
Biotyx Medical (Shenzhen) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patient must between 18 and 75 years old, male or non-pregnant female. 2. 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. 3. One or two de novo target lesions each located in a different epicardial vessel. 1. 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. 2. If two target lesions are present, they must be present in different epicardial vessels and both satisfy the angiographic eligibility criteria. 3. 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. 4. 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. 5. 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 ≥1. 6. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In-segment Late lumen loss (LLL) | 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Powered Secondary Endpoint: Cross-section level mean flow area measured by OCT | 2 years | Only for subjects in OCT subset |
| Rate of Device Success | Immediately post-procedure | Device Success is defined as: A visually estimated diameter stenosis of \< 30% after implantation of the device and TIMI flow of III. |
| Rate of Lesion Success | Immediately post-procedure | Lesion Success is defined as: The attainment of visual residual stenosis \< 30% and TIMI flow of III after any intervention in target lesion. |
| Rate of Clinical Success | ≤ 7 days post the index procedure (In-hospital ) | Clinical Success is defined as: lesion success, AND there is no major adverse cardiac event in the hospitalization period. |
| Rate of Device-oriented Composite Endpoint (DoCE) | 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years | 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). |
| Rate of Patient-oriented Composite Endpoint (PoCE) | 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years | Including all-cause mortality, any myocardial infarction and any revascularization. |
| Rate of Death (Cardiac, Vascular and Non-cardiovascular) | 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 | — |
| 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 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 | — |
| Rate of Stent Thrombosis defined by ARC (definite and probable) | 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years | 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. |
| Acute recoil | Immediately post-procedure | — |
| Powered Secondary Endpoint: Quantitative Flow Ratio (QFR) | 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 | — |
| Angiographic binary restenosis (ABR) (In-device, in-segment, proximal 5mm and distal 5mm ABR) | 2 years | — |
| Thickness of neointima (struts level) | 2 years | — |
| Minimal lumen area | 2 years | — |
| Percentage of neointima-covered struts | 2 years | — |
| Late incomplete strut apposition | 2 years | — |
| Lumen area stenosis % | 2 years | — |
| Healing score | 2 years | 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). |
| Stent Absorption (%) | 2 years | — |
| Late recoil area | 2 years | — |
| Late recoil proportion | 2 years | — |
| Minimal lumen diameter (MLD) (In-stent, in-segment, proximal 5mm and distal 5mm MLD) | at post-procedure, 2 years | — |
Countries
China
Outcome results
None listed