BuMA OCT Study(A Comparative Evaluation of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)

Sino Medical Sciences Technology Inc.80 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Coronary Heart Disease Stable Angina Pectoris

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.

The primary outcome measure is the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment.

Time frame: three months after surgery

Secondary Outcomes

Neointimal hyperplasia area/volume

It will be measure the neointimal hyperplasia area/volume at 3 months follow-up by OCT assessment.

Time frame: three months after surgery

Mean/Minimal Stent diameter/area/volume

It will be measure the Mean/Minimal stent diameter/area/volume at 3 months follow-up by OCT assessment.

Time frame: three months after surgery

Mean/Minimal Lumen diameter/area/volume

It will be measure the Mean/Minimal Lumen diameter/area/volume at 3 months follow-up by OCT assessment.

Time frame: three months after surgery

Mean/maximal thickness of the struts coverage

It will be measure the Mean/maximal thickness of the struts coverage at 3 months follow-up by OCT assessment.

Time frame: three months after surgery

Incomplete strut apposition

It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment.

Time frame: three months after surgery

Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months

Time frame: three months after surgery

Late Lumen Loss at 3 months

Time frame: three months after surgery

Binary Restenosis (DS ≥50%) at 3 months

All measurements will be made of the in-stent, in-segment, proximal and distal stent margins.

Time frame: three months after surgery

Acute success rate

It includes the device success,lesion success and procedural success.

Time frame: up to 7 days after surgery

Device-oriented Composite Endpoints and its individual components at 3 months

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: three months after surgery

Device-oriented Composite Endpoints and its individual components at 6 months

Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.

Time frame: six months after surgery

Device-oriented Composite Endpoints and its individual components at 1 year

Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.

Time frame: one year after surgery

Device-oriented Composite Endpoints and its individual components at 2 years

Device-oriented Composite Endpoint (DoCE) is defined as cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization.

Time frame: 2 years after surgery

Stent thrombosis according to the ARC definitions at 3 months

Time frame: three months after surgery

Stent thrombosis according to the ARC definitions at 6 months

Time frame: six months after surgery

Stent thrombosis according to the ARC definitions at 1 year

Time frame: one year after surgery

Stent thrombosis according to the ARC definitions at 2 years

Time frame: 2 years after surgery

BuMA OCT Study(A Comparative Evaluation of the Extent of Neointima Formation at 3 Months After Implantation Using OCT)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes