NCT01507519

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Meril Life Sciences Pvt. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Detailed description

* Principal Investigator: Dr. Sameer Dani, Interventional Cardiologist, Life Care Hospital, Ahmedbad. Mobile [phone]. * 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)

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Sirolimus Eluting Coronary Stent System (Biomime)	Coronary Artey PTCA

Timeline

• Start date: 2009-04-01
• Primary completion: 2010-10-01
• Completion: 2011-03-01
• First posted: 2012-01-11
• Last updated: 2018-04-05

Locations

1 site across 1 country: India