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

Coronary Artery Disease Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00936780
Study type Interventional
Source Sahajanand Medical Technologies Pvt. Ltd.
Contact
Status Terminated
Phase Phase 4
Start date July 2008
Completion date March 2011
View Details
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