Treatment of Moderate Vein Graft Lesions With Paclitaxel Drug Eluting Stents: The VELETI Trial

NCT ID: NCT00289835

Last Updated: 2011-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2008-10-31

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.

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.

Conditions

Coronary Artery Bypass Grafting

Keywords

Coronary Artery Bypass Grafting; Drug Eluting Stent; Saphenous Vein Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PCI-stenting

Stenting the moderate SVG lesion with the paclitaxel stent

Group Type: EXPERIMENTAL

Paclitaxel eluting stent

Intervention Type: DEVICE

Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment

Standard medical treatment

Group Type: OTHER

Paclitaxel eluting stent

Intervention Type: DEVICE

Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment

Interventions

Paclitaxel eluting stent

Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment

Intervention Type: DEVICE

Other Intervention Names

Taxus (paclitaxel eluting stent)

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Scientific Corporation

INDUSTRY

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josep Rodes-Cabau, MD

Role: PRINCIPAL_INVESTIGATOR

Laval Hospital Research Center

Olivier F Bertrand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval Hospital Research Center

Robert Delarocheliere, MD

Role: PRINCIPAL_INVESTIGATOR

Laval Hospital Research Center

Locations

Laval Hospital

Québec, Quebec, Canada

Countries

Canada

References

Rodes-Cabau J, Bertrand OF, Larose E, Dery JP, Rinfret S, Urena M, Jerez M, Nombela-Franco L, Ribeiro HB, Allende R, Proulx G, Nguyen CM, Boudreault JR, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Cote M, Despres JP, Dagenais GR, DeLarochelliere R. Five-year follow-up of the plaque sealing with paclitaxel-eluting stents vs medical therapy for the treatment of intermediate nonobstructive saphenous vein graft lesions (VELETI) trial. Can J Cardiol. 2014 Jan;30(1):138-45. doi: 10.1016/j.cjca.2013.11.002. Epub 2013 Nov 6.

Reference Type: DERIVED

PMID: 24365196 (View on PubMed)

Rodes-Cabau J, Bertrand OF, Larose E, Dery JP, Rinfret S, Bagur R, Proulx G, Nguyen CM, Cote M, Landcop MC, Boudreault JR, Rouleau J, Roy L, Gleeton O, Barbeau G, Noel B, Courtis J, Dagenais GR, Despres JP, DeLarochelliere R. Comparison of plaque sealing with paclitaxel-eluting stents versus medical therapy for the treatment of moderate nonsignificant saphenous vein graft lesions: the moderate vein graft lesion stenting with the taxus stent and intravascular ultrasound (VELETI) pilot trial. Circulation. 2009 Nov 17;120(20):1978-86. doi: 10.1161/CIRCULATIONAHA.109.874057. Epub 2009 Nov 2.

Reference Type: DERIVED

PMID: 19884468 (View on PubMed)

Other Identifiers

Laval-VG-01

Identifier Type: -

Identifier Source: org_study_id