In Stent ELUTES Study

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT00225680

Run by

Cook Group Incorporated

People needed

124

Starts

2002-04-01

Expected to finish

2005-08-01

Last updated by the study team

2012-02-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Contact Sponsor — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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