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

Study 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.

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)

Conditions
-----------------
Coronary Heart Disease, Stable Angina Pectoris, Unstable Angina Pectoris, Silent Myocardial Ischemia

Intervention / Treatment
-----------------
* Device: BuMA stent
* Device: EXCEL stent


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: BuMA stent<br>This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio). BuMA stent Arm:About 35 patients will undergoing implantation of BuMA stent.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 PCI,in order to observe the Primary Endpoint and Secondary Endpoints. | Device: BuMA stent<br>* About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy.<br>|
| Other: EXCEL stent<br>This study will enroll a total of 70 patients in Fuwai Hospital.All patients will be randomly assigned two groups(in a 1:1 ratio). EXCEL stent Arm:About 35 patients will undergoing implantation of EXCEL stent.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 PCI,in order to observe the Primary Endpoint and Secondary Endpoints. | Device: EXCEL stent<br>* About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | three months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neointimal hyperplasia area/volume | It will be measure the neointimal hyperplasia area/volume at 3 months follow-up by OCT assessment. | 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. | 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. | 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. | three months after surgery | 
| Incomplete strut apposition | It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment. | three months after surgery | 
| Minimal Lumen Diameter(MLD) and Diameter stenosis percentage(%DS) post procedure and at 3 months |  | three months after surgery | 
| Late Lumen Loss at 3 months |  | 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. | three months after surgery | 
| Acute success rate | It includes the device success,lesion success and procedural success. | 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. | 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. | 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. | 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. | 2 years after surgery | 
| Stent thrombosis according to the ARC definitions 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 1 year |  | one year after surgery | 
| Stent thrombosis according to the ARC definitions at 2 years |  | 2 years after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BuMA, EXCEL, OCT, stent, neointima formation