Status:
COMPLETED
Treatment of Moderate Vein Graft Lesions With Paclitaxel Drug Eluting Stents: The VELETI Trial
Lead Sponsor:
Laval University
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Coronary Artery Bypass Grafting
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
HYPOTHESIS 1. Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis progression as evaluated by IVUS. 2. Sealing moderate SVG lesions with the TAXUS stent does not accelerate...
Detailed Description
This will be a prospective randomized study assessing the efficacy of stenting moderate SVG lesions with the taxus stent in the prevention of atherosclerosis progression of SVGs as evaluated by IVUS. ...
Eligibility Criteria
Inclusion
- Written and signed informed consent.
- Patients ≥18 years old.
- Clinical indication for cardiac catheterization and SVG angiography.
- Presence of at least one SVG lesion of 30% to 70% diameter stenosis by visual estimation which is (are) not the culprit lesion (s) responsible for the clinical syndrome of the patient.
Exclusion
- Ejection fraction \<20%.
- Renal insufficiency with creatinine \> 250 mg/dl.
- Presence of more than 3 moderate SVG stenosis or significant diffuse SVG disease.
- Unsuccessful angioplasty (residual stenosis \>30% and/or TIMI flow \<3) of any other lesion treated during the same procedure.
- Coronary angioplasty of the target SVG in the past.
- Cardiogenic shock .
- Remaining lesion (s) with a treatment planned within the following year.
- Pregnancy.
- Contraindication to aspirin and/or clopidogrel treatment.
- Allergy to paclitaxel.
- Any disease with a limiting life-expectancy (to less than 2 years).
- Definite presence or high suspicion of thrombus or ulceration in the target lesion.
- Target lesion located in the same SVG than the culprit lesion (if present) and the distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion is \< 4 cm.
- Vein graft diameter \< 2.5 mm.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT00289835
Start Date
February 1 2006
End Date
October 1 2008
Last Update
November 24 2011
Active Locations (1)
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1
Laval Hospital
Québec, Quebec, Canada, G1V 4G5