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The FUTURE-III study is a confirmative clinical trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) after the feasibility and safety of the device has been preliminary confirmed in a small-scale First-in-Man clinical trial.
This study is a prospective, multicenter, single-arm trial in patients with coronary artery disease caused by up to two de novo native coronary artery lesions in separate epicardial vessels. The goal is to evaluate the safety and effectiveness of Firesorb to support the approval of the Chinese Food and Drug Administration (CFDA) for this product.All subjects will undergo clinical follow-up at 1-month, 6-month, 1-year, 2-year, 3-year, 4-year and 5-year post-index procedure. A total of 1200 subjects will be recruited, including 96 with long lesion (the scaffold to be used with a length of 33mm or 38mm) and 215 in the experimantal group of FUTURE-II clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental | Single Arm Safety and Effectiveness Confirmatory Study of Firesorb BVS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Firesorb | Device | Implantation of Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number and rate of Target Lesion Failure(TLF) | Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization. | 1 year after index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| The number and rate of Acute Success-Device Success | Successful delivery and deployment of the assigned scaffold at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold residual stenosis of less than 30% by visual. | From the start of index procedure to end of index procedure |
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General Inclusion Criteria:
Angiographic Inclusion Criteria:
General Specification Subgroup:
If two target lesions are present, they must be present in different epicardial vessels and both must satisfy the angiographic eligibility criteria.
Note: The definition of epicardial vessels means the LAD, LCX and RCA and their branches. Thus, the patient must not have lesions requiring treatment in e.g. both the LAD and a diagonal branch.
b. Target lesion(s) must be located in a native coronary artery with a visually estimated stenosis ≥ 70% or ≥ 50% and < 100% with clinical evidence of myocardial ischemia, a thrombolysis in myocardial infarction (TIMI) flow of ≥1. Target lesion vessel length ≤25mm by visual estimation, target vessel diameter 2.5mm-4.0mm.
c. Each target lesion may be covered with one stent.
Long Lesion Subgroup:
General Exclusion Criteria:
Angiographic Exclusion Criteria:
The following exclusion criteria apply to the target lesion(s) or target vessel(s):
(1)side branch ≥ 2.5 mm in diameter, or (2)side branch with diameter stenosis ≥ 50%, or (3)side branch requiring guide wire, or (4)side branch requiring dilatation. 4. Anatomy proximal to or within the lesion that may impair delivery of Firesorb :
7. Vessel has been previously treated with a stent at any time prior to the index procedure such that the Firesorb or XIENCE would need to cross the stent to reach the target lesion.
8. Vessel has been previously treated and the target lesion is within 5 mm proximal or distal to a previously treated lesion.
9. Lesion which prevents successful balloon pre-dilatation, defined as full balloon expansion with the following outcomes:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bo Xu, MBBS | Contact | 010-88322562 | bxu@citmd.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fu Wai Hospital | Beijing | Beijing Municipality | 100037 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40629329 | Derived | Jiang J, Li C, Chen D, Song L, Cui Z, Li P, Gan L, Chen Y, Li H, Jia S, He S, Lu W, Gao R, Wang J; FUTURE III Investigators. Firesorb bioresorbable scaffold for de novo coronary artery disease: 1-year clinical outcomes. BMC Med. 2025 Jul 9;23(1):419. doi: 10.1186/s12916-025-04254-0. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Acute Success-Procedural Success |
Achievement of final in-scaffold residual stenosis of less than 30% by visual estimation with successful delivery and deployment of at least one assigned scaffold at the intended target lesion and successful withdrawal of the delivery system for the target lesion without the occurrence of cardiac death, target vessel MI or repeat TLR. |
| At time of procedure up to 7 days in hospital |
| Device-oriented composite endpoints (Target Lesion Failure) | Target Lesion Failure is defined as the composited endpoints of cardiac death,target vessel myocardial infarction and ischemia-driven target lesion revascularization. | 1 month,6 months,2 years,3 years,4 years and 5 years after index procedure |
| Patient-oriented clinical composite endpoint (PoCE) | Patient-oriented clinical composite endpoint is defined as all cause death, all myocardial infarction, and any revascularization. | 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure |
| Death (Cardiac, Vascular, Non-cardiovascular) | Cardiac death (CD): Any death due to proximate cardiac cause (e.g. MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all procedure related deaths including those related to concomitant treatment. Non-cardiovascular death: Any death not covered by the above definitions, such as death caused by infection, malignancy, sepsis, pulmonary causes, accident, suicide or trauma. | 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure |
| The number and rate of Myocardial Infarction (MI) | Attributable to target vessel (TV-MI), Not attributable to target vessel (NTV-MI) | 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure |
| The number and rate of Target Vessel Revascularization (TVR) | Ischemia-driven TVR (ID-TVR), Not ischemia-driven TVR (NID-TVR) | 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure |
| The number and rate of Target Lesion Revascularization (TLR) | Ischemia-driven TLR (ID-TLR), Not ischemia-driven TLR (NID-TLR) | 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure |
| The number and rate of Any Revascularization | Ischemia-driven , Not ischemia-driven | 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure |
| The number and rate of Scaffold Thrombosis (per ARC definition) | Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable) Timing (acute, sub-acute, late and very late) Evidence (Definite and Probable) Timing (acute, sub-acute, late and very late), Evidence (Definite and Probable) | 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |