Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions

Launched by MERIL LIFE SCIENCES PVT. LTD. · Jan 10, 2012

Keywords

ClinConnect Summary

* 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...

Gender

ALL

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 \< 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.