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V-Flex Plus PTX Drug Eluting Coronary Stent (ELUTES III)

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, restenosis, patency, drug eluting, stent

Eligibility Criteria

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

Inclusion Criteria: Patient must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery. Patient must be an acceptable candidate for coronary artery bypass surgery Patient or legal guardian must have given informed consent Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram. Exclusion Criteria: Patient must be less than 18 years old Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions. Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study. Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye. Women of child bearing potential. Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.

Sites / Locations

  • Contact Sponsor

Outcomes

Primary Outcome Measures

Evaluation by IVUS of % diameter stenosis 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
NCT00225693
Brief Title
V-Flex Plus PTX Drug Eluting Coronary Stent
Acronym
ELUTES III
Official Title
ELUTES III - V-Flex Plus PTX Drug Eluting Coronary Stent
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Cook Group Incorporated

4. Oversight

5. Study Description

Brief Summary
The study is intended to collect data to evaluate effectiveness and safety of drug eluting stent devices in a dose ranging assessment.

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, restenosis, patency, drug eluting, stent

7. Study Design

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

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
drug eluting coronary stent
Primary Outcome Measure Information:
Title
Evaluation by IVUS of % diameter stenosis 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 must be eligible to undergo planned treatment of a single de novo lesion in a native coronary artery. Patient must be an acceptable candidate for coronary artery bypass surgery Patient or legal guardian must have given informed consent Patient agrees to return at one month for an office visit to assess cardiovascular status and at 6 months for an office visit to assess cardiovascular status, an IVUS examination and a diagnostic angiogram. Exclusion Criteria: Patient must be less than 18 years old Patient has history of bleeding diathesis or coagulopathy or will refuse blood transfusions. Patient is simultaneously participating in another investigative interventional cardiovascular device or drug study. Patient has known hypersensitivity or contraindication to aspirin, clopidogrel, or stainless steel, or a sensitivity to contrast dye. Women of child bearing potential. Patient has other medical condition that any cause non-compliance with the protocol, confound the results or is associated with limited life expectancy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Dens, MD
Organizational Affiliation
UZ Gasthuisberg Leuven
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

V-Flex Plus PTX Drug Eluting Coronary Stent

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