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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,200
Implantation of Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb)
Fu Wai Hospital
Beijing, Beijing Municipality, China
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.
Time frame: 1 year after index procedure
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.
Time frame: From the start of index procedure to end of index procedure
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
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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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure