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

Summary

Participation Requirements

Description

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 ...

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)

Tracking Information