In Stent ELUTES Study

ELUTES II - In Stent ELUTES Study

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.

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.