A Prospective, Multicenter, Randomized Comparative Evaluation of BuMA Supreme Stent and of Xience Stent in Terms of the Extent of Neointimal Formation at 1 Month and 2 Months Via OCT After Implantation in High Bleeding Risk CAD Patients（PIONEER-II OCT Study）
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Artery Disease
- Sponsor
- Sino Medical Sciences Technology Inc.
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- The percentage of the struts' neointimal coverage (%) at 1 or 2 months follow-up by OCT assessment.
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 to 85 years.
- •Evidence of myocardial ischemia without raised troponin (e.g. stable or unstable angina, silent ischemia demonstrated by positive territorial functional study).
- •Any one or more situation listed below can be considered the patient at high bleeding risk by the doctor:
- •Adjunctive oral anticoagulation treatment planned to continue after PCI；
- •Baseline Hb ≥11 g/dl (or anemia requiring TF during the prior 4 weeks)；
- •Any prior intra-cerebral bleed at any time；
- •Any stroke during the past year；
- •Hospital admission for bleeding during the prior 12 months；
- •Non-skin cancer diagnosed or treated ≤ 3 years；
- •Planned daily NSAID (other than aspirin) or steroids for ≥ 30 days after PCI；
Exclusion Criteria
- •Evidence of ongoing acute myocardial infarction in ECG prior to procedure.
- •Left ventricular ejection fraction (LVEF) \<30%.
- •The patient is a recipient of a heart transplant.
- •Known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, antiplatelet medication specified for use in the study (clopidogrel and ticlopidine), sirolimus or stainless steel, cobalt metal or sensitivity to contrast media, which cannot be adequately pre-medicated.
- •Other medical illness (e.g. skin cancer diagnosed or treated \> 3 years, neurological deficiency) or known history of substance abuse (alcohol etc.) as per physician judgment that may cause non-compliance with the protocol or confound the data interpretation or is associated with a limited life expectancy.
- •Pregnant or breastfeeding woman or woman in fertile period not taking adequate contraceptives
- •Chronic total occlusion(TIMI 0), left main lesion, intervention-required three-vessel lesions, branch vessel diameter ≥ 2.5mm and bypass lesion
- •Patients expected not to comply with 1 month DAPT；
- •Compliance with long-term single anti-platelet therapy unlikely；
- •Active bleeding at the time of inclusion；
Outcomes
Primary Outcomes
The percentage of the struts' neointimal coverage (%) at 1 or 2 months follow-up by OCT assessment.
Time Frame: 1 or 2 months
1 month OCT assessment is suitable for 1st month OCT group and 2 months OCT assessment is suitable for 2nd month OCT group
Secondary Outcomes
- bleeding events(1 or 2, 3, 6 months, 1 year, 2 years)
- Neointimal hyperplasia area/volume(1 or 2 months)
- Mean/Minimal Stent diameter/area/volume(1 or 2 months)
- Mean/Minimal Lumen diameter/area/volume(1 or 2 months)
- Mean/maximal thickness of the struts coverage(1 or 2 months)
- Incomplete strut apposition(1 or 2 months)
- Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months(1 or 2 months)
- Late Lumen Loss(1 or 2 month)
- Binary Restenosis (DS ≥50%)(1 or 2 months)
- Acute success rate(up to 7 days)
- Device-oriented Composite Endpoints and its individual components(1 or 2, 3, 6 months, 1 year, 2 years)
- Stent thrombosis according to the ARC definitions(1 or 2, 3, 6 months, 1 year, 2 years)