In Stent ELUTES Study

Not Applicable

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00225680
• Lead Sponsor: Cook Group Incorporated

Brief Summary

This trial will compare the long term safety and effectiveness of the V Flex Plus PTX Drug Eluting coronary stent with conventional treatment for in-stent restenosis for coronary arteries.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Study Completion: 2005-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-23
• Study First Posted: 2005-09-26
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-30
• Last Update Posted: 2012-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Patient has given informed consent
• Patient has target lesion in native coronary artery or coronary bypass graft
• Patient has in-stent restenosis >60%
• Patient has reference artery diameter 2.7-3.5
• Patient agrees to return for clinical assessment at 1, 6, 9, 12 and 24 months and for a treadmill test at 9 months and an angiogram at 9 months and 24 months.

Exclusion Criteria

• Patient is less than 18 years of age
• Patient is pregnant or breast feeding
• Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Patient is simultaneously participating in another investigative interventional cardiovascular drug or device study.
• Patient has known hypersensitivity or contraindication to aspirin or stainless steel or a sensitivity to contrast agent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Angiographic target vessel failure (TVF) at follow up

Secondary Outcome Measures

Name	Time	Method
Major adverse events
Target lesion revascularization

Trial Locations

Locations (1)

Contact Sponsor; 🇺🇸 Bloomington, Indiana, United States