Coronary Heart Disease, Silent Myocardial Ischemia, Stable Angina Pectoris, Unstable Angina Pectoris
Conditions
Keywords
BuMA, EXCEL, OCT, stent, neointima formation
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.
Interventions
DEVICEBuMA stent
About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy.
DEVICEEXCEL stent
About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy.
Sponsors
Sino Medical Sciences Technology Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the percentage of the struts'neointimal coverage (%) at 3 months follow-up by OCT assessment. | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean/Minimal Stent diameter/area/volume | three months after surgery | It will be measure the Mean/Minimal stent diameter/area/volume at 3 months follow-up by OCT assessment. |
| Device-oriented Composite Endpoints and its individual components at 1 year | one year after surgery | 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. |
| Mean/Minimal Lumen diameter/area/volume | three months after surgery | It will be measure the Mean/Minimal Lumen diameter/area/volume at 3 months follow-up by OCT assessment. |
| Mean/maximal thickness of the struts coverage | three months after surgery | It will be measure the Mean/maximal thickness of the struts coverage at 3 months follow-up by OCT assessment. |
| Incomplete strut apposition | three months after surgery | It will be measure the incomplete strut apposition at 3 months follow-up by OCT assessment. |
| 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 | three months after surgery | All measurements will be made of the in-stent, in-segment, proximal and distal stent margins. |
| Neointimal hyperplasia area/volume | three months after surgery | It will be measure the neointimal hyperplasia area/volume at 3 months follow-up by OCT assessment. |
| Device-oriented Composite Endpoints and its individual components at 3 months | three months after surgery | 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. |
| Device-oriented Composite Endpoints and its individual components at 6 months | six months after surgery | 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. |
| Device-oriented Composite Endpoints and its individual components at 2 years | 2 years after surgery | 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. |
| 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 | — |
| Acute success rate | up to 7 days after surgery | It includes the device success,lesion success and procedural success. |
Countries
China
Outcome results
None listed