In Stent ELUTES Study

NCT ID: NCT00225680

Last Updated: 2012-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2005-08-31

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

drug eluting coronary stent

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cook Group Incorporated

INDUSTRY

Sponsor Role: lead

Principal Investigators

Ivan DeScheerder, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of Gathuisberg

Locations

Contact Sponsor

Bloomington, Indiana, United States

Countries

United States

Other Identifiers

524

Identifier Type: -

Identifier Source: org_study_id