Study Safety and Performance of the Biomime Stent in Patients With Single, De Novo, Non-Complex Coronary Lesions — meriT-1  

Coronary Artery Disease Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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 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) ;

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

• NCT number: NCT01507519
• Study type: Interventional
• Source: Meril Life Sciences Pvt. Ltd.
• Status: Completed
• Phase: N/A
• Start date: April 2009
• Completion date: March 2011