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

NCT00289835 | Completed Phase 4

• 1 other identifier: Laval-VG-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

HYPOTHESIS

1. 1.Sealing moderate SVG lesions with the TAXUS stent prevents SVG atherosclerosis progression as evaluated by IVUS.
2. 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.
3. 3.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.
4. 4.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.

Conditions

Coronary Artery Bypass Grafting

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

  12 months

• 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

  12 months

• 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

  12 months

Secondary Outcomes (2)

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

  12 months

• SVG occlusion rate, lesion/stent late loss, minimal lumen diameter, and % diameter stenosis as assessed by angiography at 12 months follow-up

  12 months

Study Arms (2)

PCI-stenting

EXPERIMENTAL

Stenting the moderate SVG lesion with the paclitaxel stent

Device: Paclitaxel eluting stent

Standard medical treatment

OTHER

Device: Paclitaxel eluting stent

Interventions

Paclitaxel eluting stent DEVICE

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

Also known as: Taxus (paclitaxel eluting stent)

PCI-stenting; Standard medical treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Laval University: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Laval Hospital

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (2)

• 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.

  PMID: 24365196 DERIVED

• 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.

  PMID: 19884468 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2006
• First Posted: February 10, 2006
• Study Start: February 1, 2006
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: November 24, 2011

Record last verified: 2008-10

Locations

CA (1)