NCT01025869

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Atrium Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Cinatra™ Corolimus Eluting Coronary Stent System	Stent implantation

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-11-01
• Completion: 2012-03-01
• First posted: 2009-12-04
• Last updated: 2016-01-12

Locations

4 sites across 1 country: New Zealand