Clinical trial NCT01752582: BuMA OCT Study(A Comparative Evaluation of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Heart Disease
Stable Angina Pectoris
Unstable Angina Pectoris
Silent Myocardial Ischemia
Keywords: BuMA
EXCEL
OCT
stent
neointima formation
Lead sponsor: Sino Medical Sciences Technology Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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

* Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
* Total occlusion or thrombolysis in myocardial infarction(TIMI) flow 0, prior to wire crossing.

Primary outcomes:
measure: the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.
timeFrame: three months after surgery
Secondary outcomes:
measure: Neointimal hyperplasia area/volume
timeFrame: three months after surgery
measure: Mean/Minimal Stent diameter/area/volume
timeFrame: three months after surgery
measure: Mean/Minimal Lumen diameter/area/volume
timeFrame: three months after surgery
measure: Mean/maximal thickness of the struts coverage
timeFrame: three months after surgery
measure: Incomplete strut apposition
timeFrame: three months after surgery
measure: Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months
timeFrame: three months after surgery
measure: Late Lumen Loss at 3 months
timeFrame: three months after surgery
measure: Binary Restenosis (DS ≥50%) at 3 months
timeFrame: three months after surgery
measure: Acute success rate
timeFrame: up to 7 days after surgery
measure: Device-oriented Composite Endpoints and its individual components at 3 months
timeFrame: three months after surgery
measure: Device-oriented Composite Endpoints and its individual components at 6 months
timeFrame: six months after surgery
measure: Device-oriented Composite Endpoints and its individual components at 1 year
timeFrame: one year after surgery
measure: Device-oriented Composite Endpoints and its individual components at 2 years
timeFrame: 2 years after surgery
measure: Stent thrombosis according to the ARC definitions at 3 months
timeFrame: three months after surgery
measure: Stent thrombosis according to the ARC definitions at 6 months
timeFrame: six months after surgery
measure: Stent thrombosis according to the ARC definitions at 1 year
timeFrame: one year after surgery
measure: Stent thrombosis according to the ARC definitions at 2 years
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: BeiJing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Science
state: Beijing
Study officials:
affiliation: Fuwai Hospital, Chinese Academy of Medical Science
name: Yang Y Jin, president
role: PRINCIPAL_INVESTIGATOR
References: