BuMA OCT Study(A Comparative Evaluation of BuMA Stent and of EXCEL Stent in Terms of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- Sino Medical Sciences Technology Inc.
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The objective of this study is a comparative evaluation of BuMA stent and of EXCEL stent in terms of the extent of neointima formation at 3 months after implantation using OCT.
This is a prospective, single center, randomized, open-label, non-inferiority study, which will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). If non-inferiority was met, superiority test will be planned.
Detailed Description
About 70 patients with clinical evidence of ischemic heart disease and / or a positive functional study and documented stable angina pectoris (Canadian cardiovascular society classification (CCS)1, 2, 3 or 4), or documented silent ischemia in de-novo, native, previously unstented vessel in Fuwai Hospital,will be randomly assigned undergoing implantation of BuMA stent or EXCEL stent (in a 1:1 ratio). All of the patients will receive 6 months dual antiplatelet therapy and they will be followed (at the outpatient clinic) for up to 2 years. The follow-up visits will be conducted at 3 months (including angiographic/OCT investigation), 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).
- •The patient has a planned intervention of up to four de novo lesions, in different epicardial vessels.
- •Lesion(s) must have a visually estimated diameter stenosis of ≥50% and \<100%.
- •Reference Vessel Diameter(RVD) must be between 2.5-4.0 mm
- •Written informed consent.
- •The patient and the patient's physician agree to the follow-up visits including angiographic follow-up and OCT controls at 3 months.
Exclusion Criteria
- •Evidence of ongoing acute myocardial infarction in ECG prior to procedure.
- •Left ventricular ejection fraction(LVEF) \<30%.
- •Documented or suspected liver disease (including laboratory evidence of hepatitis).
- •Known renal insufficiency (e.g. estimated glomerular filtration rate(eGFR) \<60 ml/kg/m2 or serum creatinine level of \>2.5 mg/dL, or subject on dialysis).
- •History of bleeding diathesis or coagulopathy.
- •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.
- •Other medical illness (e.g. cancer, 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
- •OCT exclusion criteria
Outcomes
Primary Outcomes
the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
Time Frame: three months after surgery
The primary outcome measure is the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
Secondary Outcomes
- Binary Restenosis (DS ≥50%) at 3 months(three months after surgery)
- Neointimal hyperplasia area/volume(three months after surgery)
- Mean/Minimal Lumen diameter/area/volume(three months after surgery)
- Device-oriented Composite Endpoints and its individual components at 3 months(three months after surgery)
- Stent thrombosis according to the ARC definitions at 6 months(six months after surgery)
- Stent thrombosis according to the ARC definitions at 2 years(2 years after surgery)
- Device-oriented Composite Endpoints and its individual components at 6 months(six months after surgery)
- Mean/Minimal Stent diameter/area/volume(three months after surgery)
- Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months(three months after surgery)
- Device-oriented Composite Endpoints and its individual components at 1 year(one year after surgery)
- Stent thrombosis according to the ARC definitions at 3 months(three months after surgery)
- Stent thrombosis according to the ARC definitions at 1 year(one year after surgery)
- Mean/maximal thickness of the struts coverage(three months after surgery)
- Incomplete strut apposition(three months after surgery)
- Late Lumen Loss at 3 months(three months after surgery)
- Acute success rate(up to 7 days after surgery)
- Device-oriented Composite Endpoints and its individual components at 2 years(2 years after surgery)