NCT00689767

COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms (CONFIRM 1)

COronary Native Artery First in Man Investigation of ISA 247 Elution to Prevent Restenotic Mechanisms

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Atrium Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This First In Man study is a prospective, multicentre, single blind, randomized, controlled clinical trial of the CINATRA™ ISA 247 Coated Coronary Stent System as compared to the CINATRA™ Coronary Stent System. The study will enroll up to 100 evaluable patients at up to 7 sites. Clinical follow up will occur at 1 month, 6 months, and 1, 2, 3, 4 and 5 years post procedure. Repeat angiography and IVUS will be performed at the 6 month follow up time point for all subjects.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	CINATRA™ Coronary Stent System	Bare metal cobalt chromium stent implantation
DEVICE	CINATRA™ ISA 247 Coated Coronary Stent System	Drug coated cobalt chromium stent implantation

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-06-01
• Completion: 2012-07-01
• First posted: 2008-06-04
• Last updated: 2013-04-17

Locations

7 sites across 1 country: Belgium