This study is a small scale pilot trial for Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) in Patients with Coronary Artery Disease for the first time. The goal is to access the preliminary safety and efficacy of Firesorb implantation in the human body, and to provide evidence for subsequent large-scale, multi-center, randomized controlled clinical trials. Then provide the basis for the formal application of the product in China.
This study is a prospective, single-center clinical trial. The investigator design to recruit 45 subjects. After implanting the Sirolimus Target Eluting Bioresorbable Vascular Scaffold (Firesorb) successfully, all the subjects will be randomly assigned to queue 1 (n=30) and queue 2 (n=15). The clinical follow-up will be performed in all subjects at 1 month,6 months,1 year,2 years,3 years,4 years and 5 years after scaffold implantation. Angiographic,IVUS and OCT follow-up will be performed at 6 months and 2 years after scaffold implantation in queue 1; angiographic,IVUS and OCT follow-up will be performed at 1 year and 3 years after scaffold implantation in queue 2. The primary endpoint of the study is target lesion failure (TLF) at 30 days after scaffold implantation, the secondary endpoints are series of imaging outcomes, for evaluation of feasibility and preliminary safety and efficacy of the product.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold
Fu Wai Hospital
Beijing, Beijing Municipality, China
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 after index procedure
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: 6 months,1 year,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
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
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
Scaffold Thrombosis/Stent Thrombosis (per ARC definition)
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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
In-device, in-segment, proximal and distal minimum lumen diameter (MLD)
Angiographic endpoint.
Time frame: 6 months,1 year,2 years and 3 years after index procedure
In-device, in-segment, proximal and distal % diameter stenosis (DS)
Angiographic endpoint.
Time frame: 6 months,1 year,2 years and 3 years after index procedure
In-device, in-segment, proximal and distal angiographic binary restenosis (ABR)
Angiographic endpoint.
Time frame: 6 months,1 year,2 years and 3 years after index procedure
In-device, in-segment,proximal and distal late lumen loss (LLL)
Angiographic endpoint.
Time frame: 6 months,1 year,2 years and 3 years after index procedur
Vasomotion
The changes in average lumen diameter before and after intracoronary nitroglycerin.
Time frame: 6 months,1 year,2 years and 3 years after index procedure