NCT01507519已完成不适用
The First-In-Man Safety and Performance Evaluation of the Biomime Sirolimus Eluting Stent System for the Treatment of Patients With Single, De Novo, Non-Complex Coronary Lesions-The Biomime Pilot FiM Trial.
Meril Life Sciences Pvt. Ltd.1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MACE at 30 days clinical F/U
研究概览
简要总结
1.) Indigenously developed and designed BioMimeTM is a
- predictably safe & efficacious 3rd generation drug eluting stent (DES)
- with a propensity to minimize vascular injury by use of an intelligent mix of ultra-low strut thickness Co-Cr stent,
- highly documented drug Sirolimus &
- a biocompatible, biodegradable polymer
详细描述
- Principal Investigator: Dr. Sameer Dani, Interventional Cardiologist, Life Care Hospital, Ahmedbad. Mobile +91 98250 38855.
- Study Title: The First-In-Man Safety and Performance Evaluation of the BiomimeTM Sirolimus-Eluting Stent System for the Treatment of Patients with Single, De novo, Non-complex Coronary Lesions - The BiomimeTM Pilot FiM Trial
- Sponsor: Meril Life Sciences Pvt. Ltd.
- Study device: BiomimeTM Sirolimus-Eluting Stent (BiomimeTM SES, Meril Life Sciences)
- Study objective: To evaluate the safety and efficacy of BiomimeTM SES.
- Study design: Phase IV, prospective study to be conducted in a single centre (Life Care Hospital, Ahmedbad)
- Study population: A total of 30 patients with stable or unstable coronary disease, or silent ischemia with documented evidence of ischemia, with angiography, and, in a pre-specified subset, intravascular ultrasound (IVUS) at 8-month follow-up.
- Participating Centre: Life Care Hospital, Ahmedabad
- QCA & IVUS core lab: To be decided.
- Follow-up: All patients will undergo clinical follow-up at 1, 6, 12 and 24 months. All patients will undergo angiographic follow-up at 8 months. All patients will be submitted to intravascular ultrasound at 8 months.
- Primary safety endpoint: Major Adverse Cardiac Events (MACE) at 30 days clinical follow-up. MACE defined as any of the following: cardiac death, myocardial infarction, and ischemia driven target lesion revascularization (TLR).
- Primary efficacy endpoint:
- In-stent luminal loss assessed by quantitative coronary angiography (QCA) at 8-month follow-up
- Percentage of in-stent volume obstruction measured by IVUS at 8- month follow-up.
- Secondary endpoints:
- Occurrence of Major Adverse Cardiac Events (MACE) defined as cardiac death, non-fatal acute myocardial infarction, and need for repeat target-lesion revascularization (by cardiac bypass graft or repeat percutaneous coronary intervention up to 24 months of follow-up.
- Angiographic binary restenosis at 8 months angiographic follow-up.
- Other endpoints:
- Rates of stent thrombosis (acute, sub-acute, late and very-late) up to 24 months follow-up
- In-stent and in-segment minimum lumen diameter (MLD) and % diameter stenosis (DS) by QCA at 8-month angiographic follow-up.
- In-stent acute gain by post procedure QCA.
- Late acquired incomplete stent apposition by IVUS at 8 month follow-up.
- Primary analysis: The primary endpoint will be analyzed for all subjects who had a de novo coronary lesion enrolled in this study (intention to treat)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with > 18 years of age;
- •Symptoms of stable or unstable angina and/or presence of a positive functional test for ischemia;
- •Presence of a single de novo target lesion located in a native coronary vessel suitable for percutaneous treatment with the study stents;
- •Acceptable candidate for coronary artery bypass graft (CABG) surgery;
- •The subject is willing to sign a written informed consent prior to procedure, and is willing to undergo ALL study protocol follow-ups, including angiographic (and IVUS) follow-ups at 8 months.
- •Target lesion located in a major epicardial coronary vessel with reference of 2.5-3.5mm in diameter (by visual estimation)
- •Target lesions ≤ 19mm in length (by visual estimation) that can be treated (covered) by one single study stent (19 or 24mm in length);
- •≥ 50% and < 100% diameter stenosis;
- •TIMI (Thrombolysis In Myocardial Infarction) flow grade ≥ 2.
排除标准
- •Known hypersensitivity or contraindication to mTOR inhibitor class drugs (sirolimus), heparin, any required medications including thienopyridines, cobalt chromium, and contrast media which cannot be adequately pre medicated;
- •Patient is a female with childbearing potential;
- •Pre-treatment of the target lesion with any devices other than balloon angioplasty;
- •Previous brachytherapy in the target vessel;
- •Presence of non-target vessel lesions which require staged procedure(s) < 30 days of the index procedure;
- •Prior CABG surgery to target vessel;
- •Previous percutaneous coronary intervention (PCI) or CABG surgery < 30 days to the index procedure date;
- •Acute myocardial infarction < 3 days, with cardiac enzyme elevation including total creatine kinase (CK) > 2 times the upper normal limit value and/or CK-MB above the upper normal limit value within the past 72 hours;
- •CK and/or CK-MB levels elevated above the upper normal limit value at the time of the index procedure;
- •Documented left ventricular ejection fraction < 30%;
- •Renal insufficiency determined by a baseline serum creatinine > 2.0/dl;
- •Thrombocytopenia with a baseline platelet count < 100,000 cells/mm3;
- •Anemia with baseline hemoglobin < 10g/dL;
- •Extensive peripheral vascular disease or extreme anticoagulation that precludes safe > 5 French sheath insertion;
- •History of bleeding diathesis, coagulopathy, or will refuse blood transfusions;
- •Patients has suffered a stroke, transient ischemic attack (TIA), or cerebrovascular accident (CVA) within the past 6 months;
- •Significant gastrointestinal or genitourinary bleed within the past 6 months;
- •Patient is a recipient of a heart transplant;
- •Any elective surgical procedure is planned within 12 months of the index procedure;
- •Known illness or any serious clinical condition with life expectancy < 2 years;
- •Participation in the active or follow-up phase of any other clinical trial within 6 months;
- •Impossibility to comply with anti-platelet therapy during the study clinical follow-up;
- •Any impossibility to comply with all protocol follow-ups.
- •Target lesion or vessel with angiographic evidence of moderate or severe calcification;
- •Presence of severe tortuosity;
- •Presence of severe angulation (> 60o);
- •Presence of intraluminal thrombus;
- •Target lesion involving a bifurcation (side branch ≥ 2.0mm);
- •Target lesion located in the left main stem;
- •Aorto-ostial lesion location;
- •Target lesion involving a side branch with reference diameter ≥ 2.0mm;
- •Presence of a significant stenosis (> 40%) in the target vessel either proximal or distal to the target lesion that will be untreated;
- •Previous placement of a stent within 10mm of the target lesion;
- •Total occlusion (TIMI flow grade 0 or 1);
- •Target lesion located in an arterial or vein graft;
- •Target lesion due to in-stent restenosis;
- •Coronary anatomy unsuitable for percutaneous treatment with implantation of the available study stents.
研究组 & 干预措施
BioMime™
Experimental
BioMime™ DES
干预措施: Sirolimus Eluting Coronary Stent System (Biomime) (Device)
结局指标
主要结局
MACE at 30 days clinical F/U
时间窗: 30 days
Major Adverse Cardiac Events (MACE) at 30 days clinical follow-up. MACE defined as any of the following: cardiac death, myocardial infarction, and ischemia driven target lesion revascularization (TLR).
次要结局
- Angiographic Binary restenosis at 8-months F/U(8-months post implant)
研究者
研究点 (1)
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