In Stent ELUTES Study (ELUTES II)

Cook Group

Status

Completed

Conditions

Coronary Artery Disease

Treatments

Device: drug eluting coronary stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00225680

524

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.