The Galaxy First-in-man study is a small pilot. single arm research , which will enroll a total of 45 patients. The goal is to access the feasibility, safety and efficacy of Rapamycin Drug-Eluting Bioresorbable Coronary Stent System in the treatment of patients with de novo coronary lesion.
This study is a prospective, single arm clinical trial. 45 patients enrolled in the study will be randomly assigned to queue1 (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 stent implantation; angiographic,IVUS and OCT follow-up will be performed at 6 months and 2 years after stent implantation in queue 1; angiographic,IVUS and OCT follow-up will be performed at 1 year and 3 years after stent implantation in queue 2. The primary endpoint of the study is target lesion failure (TLF) at 30 days after stent implantation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
Implantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
Device-related composite endpoints (Target Lesion Failure)
contains cardiac death,target vessel myocardial infarction and clinical driven-target lesion revascularization
Time frame: 1 month after stent implantation
Device Success
Successful delivery and deployment of the assigned stent at the intended target lesion and successful withdrawal of the delivery system with attainment of final in-stent residual stenosis of less than 30% by quantitative coronary angiography (QCA)
Time frame: From the start of index procedure to end of index procedure
Procedural Success
Achievement of final in-stent residual stenosis of less than 30% by QCA (by visual estimation if QCA unavailable) with successful delivery and deployment of at least one assigned 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
Target Lesion Failure
Target lesion failure is a composite endpoint of cardiac death, target vessel related myocardial infarction (TV-MI) and the ischemia-driven target lesion revascularization
Time frame: 6 months
Target Lesion Failure
Time frame: 1 year
Target Lesion Failure
Time frame: 2 years
Target Lesion Failure
Time frame: 3 years
Target Lesion Failure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 4 years
Target Lesion Failure
Time frame: 5 years
Patient Oriented Composite Endpoint
Patients oriented composite endpoint includes all-cause death, all myocardial infarction and any revascularization
Time frame: 30 days
Patient Oriented Composite Endpoint
Time frame: 6 months
Patient Oriented Composite Endpoint
Time frame: 1 year
Patient Oriented Composite Endpoint
Time frame: 2 years
Patient Oriented Composite Endpoint
Time frame: 3 years
Patient Oriented Composite Endpoint
Time frame: 4 years
Patient Oriented Composite Endpoint
Time frame: 5 years
Stent Thrombosis
Time frame: 30 days
Stent Thrombosis
Time frame: 6 months
Stent Thrombosis
Time frame: 1 year
Stent Thrombosis
Time frame: 2 years
Stent Thrombosis
Time frame: 3 years
Stent Thrombosis
Time frame: 4 years
Stent Thrombosis
Time frame: 5 years
Minimal lumen diameter
Time frame: 6 months, 1year, 2 years and 3years
In-stent stenosis
Time frame: 6 months, 1year, 2 years and 3years
Late lumen loss
Time frame: 6 months, 1year, 2 years and 3years
Covered struts percentage
Time frame: 6 months, 1year, 2 years and 3years
Malapposed struts percentage
Time frame: 6 months, 1year, 2 years and 3years
Neointimal hyperplasia area
Time frame: 6 months, 1year, 2 years and 3years
Neointimal hyperplasia area obstruction
Time frame: 6 months, 1year, 2 years and 3years
Struts core area
Time frame: 6 months, 1year, 2 years and 3years
Struts neointimal thickness
Time frame: 6 months, 1year, 2 years and 3years
IVUS mean vessel area
Time frame: 6 months, 1year, 2 years and 3years
IVUS mean lumen area
Time frame: 6 months, 1year, 2 years and 3years
IVUS mean strut area
Time frame: 6 months, 1year, 2 years and 3years