The objective of this study is a comparative evaluation of BuMA Supreme™ stent and of Xience V/Prime stent in terms of the extent of neointima formation at 1 or 2 months after implanting in relatively high bleeding risk patients with coronary artery disease using OCT.
This is a prospective, multicenter, randomized, non-inferiority study, which will enroll a total of 80 subjects from approximately 8 centers. All subjects will be firstly randomly assigned to 1st month OCT (40 pts) or 2nd month OCT group(40 pts). Then both two groups will be randomly assigned to undergoing implantation of BuMA Supreme™ stent (20 pts) or Xience V/Prime stent (20 pts). If non-inferiority was met, superiority test will be planned. All of the patients be followed up to 2 years. The follow-up visits will be conducted at 1 or 2 months (including QCA/OCT investigation), 3 months, 6 months, 1 and 2 years post percutaneous coronary intervention(PCI),in order to observe the Primary Endpoint and Secondary Endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
82
The PLA General Hospital
Beijing, Beijing Municipality, China
The percentage of the struts' neointimal coverage (%) at 1 or 2 months follow-up by OCT assessment.
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
Time frame: 1 or 2 months
Neointimal hyperplasia area/volume
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
Time frame: 1 or 2 months
Mean/Minimal Stent diameter/area/volume
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
Time frame: 1 or 2 months
Mean/Minimal Lumen diameter/area/volume
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
Time frame: 1 or 2 months
Mean/maximal thickness of the struts coverage
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
Time frame: 1 or 2 months
Incomplete strut apposition
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
Time frame: 1 or 2 months
Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
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Time frame: 1 or 2 months
Late Lumen Loss
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
Time frame: 1 or 2 month
Binary Restenosis (DS ≥50%)
All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.
Time frame: 1 or 2 months
Acute success rate
It includes the device success,lesion success and procedural success.
Time frame: up to 7 days
Device-oriented Composite Endpoints and its individual components
Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, Myocardial Infarction(MI) not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.
Time frame: 1 or 2, 3, 6 months, 1 year, 2 years
Stent thrombosis according to the ARC definitions
Definite and probable stent thrombosis during acute, subacute, later and very late phase.
Time frame: 1 or 2, 3, 6 months, 1 year, 2 years
bleeding events
Time frame: 1 or 2, 3, 6 months, 1 year, 2 years