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, non-randomized trial * Study population: 15 patients * Clinical follow up will be required at postoperative, 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years; * All the subjects perform the angiography, Intra-vascular ultrasound (IVUS) and Optical coherence tomography (OCT) at 1 year and 3 years. * The primary study endpoint is target lesion failure (TLF) at 1 month post procedure; and imaging findings as the secondary study endpoint. To evaluate the feasibility, safety and performance of IBS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)
Institut Jantung Negara
Kuala Lumpur, Negeri Selangor, Malaysia
NOT_YET_RECRUITINGUniversity Malaya Medical Centre
Kuala Lumpur, Negeri Selangor, Malaysia
RECRUITINGStudy 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: 1 month 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 postoperative
Clinical Success
Defined as based on lesion success, there is no major adverse cardiac events in the hospitalization period.
Time frame: Hospitalized period postoperative 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 postoperative
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), also known as MACE (major adverse cardiac events).
Time frame: 6 Month, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure
Patient related Clinical Composite Endpoint (PoCE)
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Including all-cause mortality, all myocardial infarction and target lesion revascularization.
Time frame: 30 Days, 6 Months, 1 Year, 2 Years, 3 Years, 4 Years, 5 Years postprocedure
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)
Acute stent retraction
Angiographic Endpoint
Time frame: Immediate postoperative
In-stent, in-segment, proximal and distal minimum lumen diameter (MLD)
Angiographic Endpoint
Time frame: Immediate postoperative, 1 year, 3 years
In-stent, in-segment, proximal and distal Diameter stenosis(DS)
Angiographic Endpoint
Time frame: 1 year, 3 years
In-stent, in-segment, proximal and distal Late lumen loss (LLL)
Angiographic Endpoint
Time frame: 1 year, 3 years
In-stent, in-segment, proximal and distal Angiographic defined restenosis (ABR)
Angiographic Endpoint
Time frame: 1 year, 3 years
Vasomotion
Defined as the average diameter change of lumen diameter before and after using nitroglycerin.
Time frame: 1 year, 3 years
Analysis of Morphometric, lesion composition and scaffold strut data obtained with OCT
Optical Coherence Tomography Endpoint
Time frame: : Immediate postoperative, 1 year, 3 years
Analysis of Vascular and scaffold morphology obtained with IVUS
Intra-Vascular Ultrasound Endpoint
Time frame: Immediate postoperative,1 year, 3 years