A Prospective Evaluation of BioMime™ - Sirolimus Eluting Coronary Stent in a Multi- Centre Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 11
- 主要终点
- Major Adverse Cardiac Events (MACE) days
研究概览
简要总结
This is a multi centre, prospective trial. 250 patients will be enrolled in the study.(10 patients per centre involving approximately 25 centres). Patients will be followed up clinically for twelve months post-procedure at 1 month, 6 months & 12 months. All patients will have a repeat angiography at 8 months. Clinical follow-up will be maintained for years 3 & 5 post-implant.
详细描述
This is a multi centre, prospective observational study. 250 patients will be enrolled in the study. 10 patients per centre involving approximately 25 centres. All the patients will be followed for twelve months post-procedure. All patients will have a repeat angiography assessment at 8 months. An additional clinical follow-up will be maintained for years 3 & 5 post-implant.
Approximately 250 patients with obstructive coronary artery disease with a vessel size between ≥2.5 to ≤3.5 mm in diameter by visual estimate and who meet all eligibility criteria will be treated with the Sirolimus Eluting Stent.
It is anticipated that the total length of the study will be 16 months: 4 months to complete patient enrollment and 12 months for angiographic follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be ≥18 years of age;
- •Patient is an acceptable candidate for PTCA, Stenting, or Emergent CABG;
- •Symptomatic ischemic heart disease (CCS class 1-4 , Braunwald class IB, IC, IIB, IIC,IIIB,IIIC) and/or objective evidence of myocardial ischemia;
- •TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2 ;
- •C.T.O's (Chronic Total Occlusions) and Bifurcation Lesions may also be attempted;
- •Target lesion stenosis is >50% and <100% ;
- •Target lesions are de novo;
- •Target lesions ≤ 35mm in length (by visual estimation) that can be treated (covered) by one single study stent (13 to 40mm in length)
- •Target lesion located in a major epicardial coronary vessel with reference of ≥ 2.5 - ≤ 3.5mm in diameter (by visual estimation)
- •Target lesions which can be covered by one stent, no overlapping allowed (lesion stent ratio of at least 1.5)
- •The patient and/or his legal representative has been informed of the nature of the study and agrees to its provisions and has provided a written informed consent.
排除标准
- •General exclusion criteria:
- •Women of childbearing potential;
- •Impaired renal function (creatinine > 2.0 mg/dl or 180 μmol/l);
- •Any patient who has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of Hepatitis;
- •Recipient of an organ (Heart, Kidney, Lung or Liver) transplant;
- •History of CVA or TIA within the last 3 months
- •Patient with a concomitant disease having a life expectancy of less than 12 months;
- •Known allergies or contraindication to mTOR inhibitor class of drugs (Sirolimus), Aspirin, Clopidogrel Bisulphate (Plavix®), Heparin, Cobalt Chromium/Nickel, contrast media;
- •Any significant medical condition which in the investigator's opinion may interfere with the patient's optimal participation in the study such as an active infection or peptic ulcer or upper GI bleeding;
- •Currently participating in an investigational drug or another device study, or subject to inclusion in another investigational drug or another device study during follow-up.
- •Clinically relevant contraindication to aspirin, heparin, clopidogrel bisulphate, including thrombocytopenia, neutropenia, or leukopenia
- •Patients with Cardiogenic Shock.
- •Angiographic Exclusion criteria:
- •Left main coronary artery disease with ≥ 50% stenosis,
- •Angiographic evidence of thrombus (thrombus larger than half the diameter of the vessel and/or requiring other adjunctive interventions such as Angiojet, Exciser, Thrombolysis, etc.),
- •Left Ventricular Ejection Fraction ≤30 %,
- •Saphenous Vein Graft Interventions, (S.V.G's)
- •Patients presenting with an ongoing Acute Myocardial Infarction (AMI),
- •Patients having undergone a PCI within 48 hours of an AMI episode.
结局指标
主要结局
Major Adverse Cardiac Events (MACE) days
时间窗: 30 days
composite of Death, MI (both Q-wave and Non Q-wave MI), Emergent CABG, or Clinically driven TLR (repeat PCI or CABG) and measured percentage wise
次要结局
- Device related SAEs(Until 12 months)
- Angioghraphic stent thrombosis(After 30 days until 12 months)
- Major Adverse Cardiac Events (MACE)(Until 12 months)
- Angiographic/Device success, Procedural Success, Clinically justified Target Lesion Revascularization(At 12 months)