Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents

NCT01223443 | Terminated Phase 4 DMC

• 1 other identifier: VELETI II
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: Sealing moderate SVG lesions with paclitaxel-eluting stents reduces cardiac events (death, myocardial infarction, target vessel revascularization) over the duration of follow-up. Primary objective: To evaluate the efficacy of stenting moderate SVG lesions with paclitaxel-eluting stents on reducing the first occurrence of the composite of cardiac death, myocardial infarction or repeat revascularization related to the target SVG over the duration of follow-up (minimun of 2-year follow-up.

Conditions

Coronary Artery Bypass Grafting

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The first occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization related to the target SVG over the duration of follow-up.

  60 months

Secondary Outcomes (7)

• 1-First occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization over the duration of follow-up.

  60 months

• 2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome.

  60 months

• 3-Total medical costs (at index hospitalization and at follow-up).

  60 months

• 4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented.

  60 months

• 5-Severe (>60%) SVG lesions or SVG occlusion at the target SVG at 2-year follow-up as determined by 3D computed-tomography.

  60 months

Study Arms (2)

PCI-stenting

EXPERIMENTAL

Stenting the moderate SVG lesion with the paclitaxel stent

Device: Paclitaxel eluting stent

Standard medical treatment

NO INTERVENTION

Interventions

Paclitaxel eluting stent DEVICE

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

PCI-stenting

Eligibility Criteria

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

You may qualify if:

• Clinical indication for cardiac catheterization and SVG angiography
• Presence of at least one SVG lesion of 30% to 60% diameter stenoses, by visual estimation, which is not the culprit lesion\* responsible for the clinical syndrome of the patient
• \*If the target lesion is located in the same SVG than the culprit lesion (if present) it has to be at least 4 cm far from the stented segment)
• Written informed consent

You may not qualify if:

• Patient \< 18 years old
• Ejection fraction \< 30%
• Renal insufficiency with creatinine \> 200 μmol/l
• Presence of more than 2 moderate SVG stenoses in a single SVG or significant diffuse SVG disease defined as disease covering more than half of the length of the SVG
• Presence of more than 2 SVGs with moderate SVG stenoses
• Unsuccessful angioplasty (residual stenosis \>30% and/or TIMI flow \<3) of any other lesion treated during the same procedure (culprit lesions will be treated before patient randomization)
• Any significant complication occurring during the angioplasty of the culprit lesion(s) during the same procedure
• SVG lesion located at the distal anastomosis
• SVG lesions located at the proximal anastomosis (lesion length \< 5 mm from the SVG ostium)
• Lesion length \>25 mm
• SVGs ≤ 3 years ago
• Cardiogenic shock
• Remaining coronary or SVG lesion(s) with treatment (PCI or CABG) planned within the following year
• Pregnancy
• Contraindication to aspirin and/or thienopyridine/ticagrelor treatment

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec: lead
• Boston Scientific Corporation: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, G1V 4G5, Canada

Location

Related Publications (1)

• Rodes-Cabau J, Jolly SS, Cairns J, Mansour S, L'Allier PL, Teefy PJ, Graham JJ, Le May MR, Cantor WJ, Wood D, Balasubramanian K, DeLarochelliere R, Dzavik V; VELETI II Investigators (Sealing Moderate Coronary Saphenous Vein Graft Lesions With Paclitaxel-Eluting Stents). Sealing Intermediate Nonobstructive Coronary Saphenous Vein Graft Lesions With Drug-Eluting Stents as a New Approach to Reducing Cardiac Events: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2016 Nov;9(11):e004336. doi: 10.1161/CIRCINTERVENTIONS.116.004336.

  PMID: 27815344 DERIVED

Study Officials

• Josep Rodes-Cabau, MD

  Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: September 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

CA (1)