NCT00936780

Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions

Safety and Efficacy of the Infinnium-Core™ Paclitaxel-Eluting Coronary Stent System for the Treatment of Patients With De Novo Coronary Lesions

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Sahajanand Medical Technologies Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.

Detailed description

Infinnium-Core™ Registry is a multi-centric, prospective study. Approximately 150 patients will be enrolled in the study. Patients will be followed for two years post-procedure. Data analysis will include all statistically pre assigned 20% patients and all patients who have repeat angiography due to complication. The diabetic patients will be specified as a high risk subset in this study.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Infinnium-Core™ Paclitaxel eluting Coronary Stent	Infinnium-Core™ Coronary Stent System consisting of the Coronnium® coronary stent (CE approved) having Biodegradable Polymeric Matrix on a Co-Cr alloy Platform. Drug concentration is 1.36 µg/mm2.

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-07-10
• Last updated: 2012-08-23

Locations

7 sites across 1 country: India