Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00289835
Status:
COMPLETED
Last Update Posted:
2011-11-24
First Post:
2006-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment of Moderate Vein Graft Lesions With Paclitaxel Drug Eluting Stents: The VELETI Trial
Sponsor:
Laval University
Organization:
Study Overview
Official Title:
Sealing Moderate Coronary Saphenous VEin Graft LEsions With the Paclitaxel-eluting Stent (Taxus) as a New Approach to Maintain Vein Graft Patency and Reduce Cardiac Events: a Pilot Intravascular Ultrasound Study.
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VELETI
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 SVG atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by IVUS.
OBJECTIVES
1. To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on limiting SVG disease progression as evaluated by IVUS.
2. To evaluate by IVUS the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis progression in angiographically non-diseased SVGs segments.
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 SVG atherosclerosis in the angiographically non-diseased segments of the SVG as evaluated by IVUS.
OBJECTIVES
1. To determine the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on limiting SVG disease progression as evaluated by IVUS.
2. To evaluate by IVUS the effect of stenting moderate SVG lesions with the paclitaxel-eluting stent in comparison with medical treatment on atherosclerosis progression in angiographically non-diseased SVGs segments.
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. Patients with previous coronary bypass surgery with SVG implantation undergoing coronary angiography by clinical indication will be screened. If the patient has a moderate lesion at any level of the SVGs it will be includable in the study. After inclusion, the patients will be randomized to either stenting the moderate SVG lesion with the taxus stent or standard medical treatment. The use of a filter wire during dilation will be strongly recommended. Following this procedure, all patients will have clinical controls at 1 month and at 6 months and an angiographic and IVUS control study at 1 year follow-up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: