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

This study has been completed.
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT00289835
First received: February 9, 2006
Last updated: November 23, 2011
Last verified: October 2008
  Purpose

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.

Condition Intervention Phase
Coronary Artery Bypass Grafting
Device: Paclitaxel eluting stent
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Ultrasound lumen area and minimal lumen diameter at follow-up at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change between baseline and follow-up in ultrasound lumen area and minimal lumen diameter (% and absolute value) at the tomographic section showing the most severe stenosis, comparing stented vs medically treated SVGs lesions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in atheroma volume (% and absolute value) as evaluated by IVUS between baseline and follow-up in an angiographically non-diseased 40 mm segment (excluding the target lesion), comparing stented vs medically treated SVGs [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cumulative incidence of clinical events (cardiovascular death, myocardial infarction, repeat revascularization) at 12 months follow-up [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • SVG occlusion rate, lesion/stent late loss, minimal lumen diameter, and % diameter stenosis as assessed by angiography at 12 months follow-up [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: February 2006
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PCI-stenting
Stenting the moderate SVG lesion with the paclitaxel stent
Device: Paclitaxel eluting stent
Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment
Other Name: Taxus (paclitaxel eluting stent)
Standard medical treatment Device: Paclitaxel eluting stent
Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment
Other Name: Taxus (paclitaxel eluting stent)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289835

Locations
Canada
Laval Hospital
Quebec, Canada, G1V 4G5
Sponsors and Collaborators
Laval University
Boston Scientific Corporation
Investigators
Principal Investigator: Josep Rodes-Cabau, MD Laval Hospital Research Center
Principal Investigator: Olivier F Bertrand, MD, PhD Laval Hospital Research Center
Principal Investigator: Robert Delarocheliere, MD Laval Hospital Research Center
  More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT00289835     History of Changes
Other Study ID Numbers: Laval-VG-01
Study First Received: February 9, 2006
Last Updated: November 23, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Laval University:
Coronary Artery Bypass Grafting
Drug Eluting Stent
Saphenous Vein Graft

Additional relevant MeSH terms:
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 21, 2014