Coronary Artery Disease
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Subjects in this arm will be treated with IBS
Sponsors
Biotyx Medical (Shenzhen) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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 registration of the subject. 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 5-year follow-ups.
Exclusion criteria
* General
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of target lesion failure | 1 year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 events 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 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 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, and very late. |
| 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 | — |
Countries
China
Outcome results
None listed