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In Stent ELUTES Study (ELUTES II)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
drug eluting coronary stent
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery, stent, drug eluting, patency, restenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Contact Sponsor

Outcomes

Primary Outcome Measures

Angiographic target vessel failure (TVF) at follow up

Secondary Outcome Measures

Major adverse events
Target lesion revascularization

Full Information

First Posted
September 12, 2005
Last Updated
January 30, 2012
Sponsor
Cook Group Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00225680
Brief Title
In Stent ELUTES Study
Acronym
ELUTES II
Official Title
ELUTES II - In Stent ELUTES Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery, stent, drug eluting, patency, restenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
124 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
drug eluting coronary stent
Primary Outcome Measure Information:
Title
Angiographic target vessel failure (TVF) at follow up
Secondary Outcome Measure Information:
Title
Major adverse events
Title
Target lesion revascularization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan DeScheerder, MD
Organizational Affiliation
University Hospital of Gathuisberg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Contact Sponsor
City
Bloomington
State/Province
Indiana
Country
United States

12. IPD Sharing Statement

Learn more about this trial

In Stent ELUTES Study

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