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OpenTrials
Completed

NCT Number: NCT00289835

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

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.

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Key information

Conditions

Coronary Artery Bypass Grafting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Laval Hospital

Québec, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Paclitaxel Eluting Stent

Device

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

Other names: Taxus (paclitaxel eluting stent)

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Cumulative incidence of clinical events (cardiovascular death, myocardial infarction, repeat revascularization) at 12 months follow-up

    Time frame: 12 months

  2. 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

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Official study 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.

Acronym: VELETI

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 10, 2006
Registry last updated
Nov 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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