In Stent ELUTES Study

Coronary Artery Disease Clinical Trial

— ELUTES II  

Official title:

ELUTES II - In Stent ELUTES Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225680
• Other study ID #: 524
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: January 30, 2012
• Start date: April 2002
• Est. completion date: August 2005

Study information

• Verified date: January 2012
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• drug eluting coronary stent

Locations

Country	Name	City	State
United States	Contact Sponsor	Bloomington	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Angiographic target vessel failure (TVF) at follow up
Secondary	Major adverse events
Secondary	Target lesion revascularization