study safety and performance of the biomime stent in patients with single, de novo, non-complex coronary lesions

Conditions: Coronary Artery Disease

Summary: 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

* 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)

Eligibility criteria:
inclusion criteria: * 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. exclusion criteria: * 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 \ 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.