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The Clinical Evaluation of the Cinatra™ Corolimus -Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries

2014-07-23 21:11:33 | BioPortfolio

Summary

To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the treatment of de novo lesions in native coronary arteries.

Description

This is a single-arm, multicentre pilot study designed to provide an indication of the effectiveness and safety of the Cinatra™ Corolimus Eluting Coronary Stent System. The primary endpoint to be evaluated in this study is late lumen loss (in-stent) at 6 months post-procedure as measured by QCA in the 30 participants undergoing angiography at this timepoint. Late lumen loss is defined as the difference between the post-index procedure minimal lumen diameter (MLD) and the follow-up MLD.

Study Design

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

Conditions

Coronary Artery Disease

Intervention

Cinatra™ Corolimus Eluting Coronary Stent System

Location

Auckland City Hospital
Auckland
New Zealand

Status

Recruiting

Source

Atrium Medical Corporation

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:33-0400

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