The study is a pilot clinical trial for Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System(IBS). The main purpose of this study is to evaluate the feasibility, preliminary safety and efficacy of IBS. To provide the basis for subsequent large-scale, multi-center, randomized controlled clinical trials of IBS.
A prospective, single-center, First-in-Man trial; Study population: 45 subjects. 45 subjects will be randomly assigned into two cohorts: cohort 1(n=30), cohort 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, 5 years post procedure; The Angiographic, Intra-Vascular Ultrasound (IVUS) and Optical Coherence Tomography (OCT) will be performed at 6 months and 2 years post procedure in cohort 1. The Angiographic, IVUS and OCT will be performed at 1 year and 3 years post procedure in cohort 2. The primary study endpoints: 1. Target lesion failure (TLF) at 6 months post procedure 2. Late Lumen Loss at 6 months post procedure
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)
Beijing Fuwai hospital
Beijing, China
Study Device related Composite Endpoint (Target Lesion Failure)
Target Lesion Failure is defined as the composited endpoints of including cardiac death, Target vessel related myocardial infarction (TV-MI) and clinical indicated target lesion revascularization (CI-TLR), also known as MACE (major adverse cardiac events).
Time frame: 6 months after implantation
Late Lumen Loss
Late Lumen Loss
Time frame: 6 months after implantation
Immediate Success Rate
1. Device Success: Successfully transit and release the IBS at target lesion, then withdraw the delivery system. Immediate residual stenosis \< 30% and TIMI blood flow is class 3 (visual). 2. Lesion Success: Any method of intervention therapy, the residual stenosis of the target lesion \< 30% and TIMI blood flow is class 3(visual).
Time frame: Immediate post procedure
Clinical Success
Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period.
Time frame: Hospitalized period post procedure within 7 days
Performance Evaluation of IBS
4 class (Excellent, good, general, bad) to evaluate the push ability, performance of through the lesions, performance of cover the lesions, support force, withdraw ability.
Time frame: Immediate post procedure
Device related Composite Endpoint (DoCE)
Target Lesion Failure, defined as the composited endpoints of including cardiac death, target vessel related myocardial infarction (TV-MI) and clinical indicated target lesion revascularization (CI-TLR).
Time frame: 1 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure
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Patient related Clinical Composite Endpoint (PoCE)
Including all-cause mortality, all myocardial infarction and any revascularization.
Time frame: 1 Month, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years post procedure
Stent Thrombosis defined by ARC
Timing (acute, sub-acute, late and very late) Evidence (definite and probable)
Time frame: Acute (0-24 hours), Subacute (24 hours-30 days), Late (30 days-1 year), Very late (after 1 year)
Thickness of acute stent recoil (mm)
Angiographic Endpoint
Time frame: Immediate post procedure
In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)
Angiographic Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
In-stent, in-segment, proximal and distal percent of diameter stenosis (DS, %)
Angiographic Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
In-stent, in-segment, proximal and distal late lumen loss (LLL)
Angiographic Endpoint
Time frame: 1 year, 2 years, 3 years
In-stent, in-segment, proximal and distal angiographic defined restenosis (ABR)
Angiographic Endpoint
Time frame: 6 months, 1 year, 2 years, 3 years
Vasomotion
Defined as the average diameter change of lumen diameter before and after using nitroglycerin.
Time frame: 6 months,1 year, 2 years, 3 years
Analysis of neointimal thickness by OCT
Optical Coherence Tomography Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of proportion of strut coverage by OCT
Optical Coherence Tomography Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of incomplete strut apposition by OCT
Optical Coherence Tomography Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of percentage area obstruction by OCT
Optical Coherence Tomography Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of healing score by OCT
Optical Coherence Tomography Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of late recoil by OCT
Optical Coherence Tomography Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of vessel area by IVUS
Intra-Vascular Ultrasound Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of lumen area by IVUS
Intra-Vascular Ultrasound Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of scaffold area by IVUS
Intra-Vascular Ultrasound Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of neointimal area by IVUS
Intra-Vascular Ultrasound Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of percentage area obstruction by IVUS
Intra-Vascular Ultrasound Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of volumetric obstruction by IVUS
Intra-Vascular Ultrasound Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years
Analysis of late recoil area by IVUS
Intra-Vascular Ultrasound Endpoint
Time frame: Immediate post procedure, 6 months, 1 year, 2 years, 3 years