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

NCT ID: NCT01223443

Last Updated: 2016-10-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2016-09-30

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.

Detailed Description

This is a prospective, multicenter, randomized study assessing the efficacy of stenting moderate SVG lesions (30% to 60% by visual estimation) with paclitaxel-eluting stents in the prevention of SVG atherosclerosis progression and cardiac events at follow-up. 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. Following this procedure, all patients will have follow-up visits by telephone or clinic at 30 days, 180 days, 1 year, and yearly until the common study end date. The duration of the study will be approximately 4 years with a minimun of 2-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: NO_INTERVENTION

No interventions assigned to this group

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

Eligibility Criteria

Inclusion Criteria

1. Clinical indication for cardiac catheterization and SVG angiography

2. 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)

3. Written informed consent

Exclusion Criteria

1. Patient < 18 years old

2. Ejection fraction < 30%

3. Renal insufficiency with creatinine > 200 μmol/l

4. 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

5. Presence of more than 2 SVGs with moderate SVG stenoses

6. 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)

7. Any significant complication occurring during the angioplasty of the culprit lesion(s) during the same procedure

8. SVG lesion located at the distal anastomosis

9. SVG lesions located at the proximal anastomosis (lesion length < 5 mm from the SVG ostium)

10. Lesion length >25 mm

11. SVGs ≤ 3 years ago

12. Cardiogenic shock

13. Remaining coronary or SVG lesion(s) with treatment (PCI or CABG) planned within the following year

14. Pregnancy

15. Contraindication to aspirin and/or thienopyridine/ticagrelor treatment

16. Allergy to paclitaxel

17. Any disease with a limiting life-expectancy (less than 2 years)

18. Need for chronic anticoagulation treatment

19. Definite presence or high suspicion of thrombus or ulceration in the target lesion

20. Target lesion located in the same SVG as the culprit lesion (if present) and distance between the target lesion and the most proximal or distal part of the stent implanted at the culprit lesion < 4 cm

21. 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

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec

OTHER

Sponsor Role: lead

Responsible Party

Josep Rodes-Cabau

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josep Rodes-Cabau, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 27815344 (View on PubMed)

Other Identifiers

VELETI II

Identifier Type: -

Identifier Source: org_study_id