V-Flex Plus PTX Drug Eluting Coronary Stent

Completed · Not applicable

Conditions studied: Coronary Artery Disease

In brief

The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.

Key facts

Study ID

NCT00225693

Run by

Cook Group Incorporated

People needed

150

Starts

2003-10-01

Expected to finish

2005-07-01

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 must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery.
• Patient must be an acceptable candidate for coronary artery bypass surgery
• Patient or legal guardian must have given informed consent
• Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram.

You may not qualify if…

• Patient must be less than 18 years old
• Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
• Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study.
• Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye.
• Women of child bearing potential.
• Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.

Where it is running

• Contact Sponsor — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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