The FUTURE-II 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-blind, randomized controlled 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. The Abbott's XIENCE Everolimus-eluting Coronary Stent System is selected as the control device. 430 subjects will be recruited. All subjects will be 1:1 randomly assigned to experimental group and control group. 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. All subjects will undergo angiographic follow-up at 1-year post-index procedure; of which 3-5 centers will be specified as a subgroup to complete OCT follow-up (n=80, 40 each in test and control group).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
430
Fu Wai Hospital
Beijing, Beijing Municipality, China
In-segment Late Lumen Loss (LLL) (Queue 1)
In-segment late lumen loss is defined as the change in minimal lumen diameter (MLD) within the margins of the scaffold/stent and 5mm proximal and 5mm distal to the scaffold/stent from post-procedure to 1 year by angiography.
Time frame: 1 year after index procedure
The percentage of intima coverage-strut (OCT subgroup)
The main secondary endpoint
Time frame: 1 year after index procedure
Acute Success-Device Success
Successful delivery and deployment of the assigned scaffold/stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-scaffold/stent 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/stent residual stenosis of less than 30% by visual estimation with successful delivery and deployment of at least one assigned scaffold/stent 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 clinical driven-target lesion revascularization.
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Patient-oriented clinical composite endpoint (PoCE)
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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
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
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
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
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
Any Revascularization
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Scaffold/Stent Thrombosis (per ARC definition)
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
Site Diagnosed Angina (SDA)
Defined as the study unit by collecting Seattle angina questionnaire (SAQ), doctor angina questionnaire and research units of AE reports incidence of angina pectoris (excludes angina pectoris 0-7 days after index procedure ).
Time frame: 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after index procedure
Minimum Lumen Diameter (MLD)
Including in-scaffold/stent, in-segment lesion, the proximal 5mm of stent, and the distal 5mm of stent.
Time frame: 1 year after index procedure
percentage of diameter stenosis (%DS)
Including in-scaffold/stent, in-segment lesion, the proximal 5mm of stent, and the distal 5mm of stent.
Time frame: 1 year after index procedure
Angiographic Binary Restenosis (ABR)
Including in-scaffold/stent, in-segment lesion, the proximal 5mm of stent, and the distal 5mm of stent.
Time frame: 1 year after index procedure
Late Lumen Loss (LLL)
Including in-scaffold/stent, in-segment lesion, the proximal 5mm of stent, and the distal 5mm of stent.
Time frame: 1 year after index procedure
Acute Stent Recoil
Time frame: Immediately after index procedure
Descriptive analysis of morphometric, lesion composition and scaffold strut data obtained with OCT
OCT endpoint
Time frame: 1 year after index procedure