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

Coronary Artery Bypass Grafting Clinical Trial

— VELETI II  

Official title:

Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents as a New Approach to MainTaining VeIn Graft Patency and Reducing Cardiac Events

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01223443
• Other study ID #: VELETI II
• Status: Terminated
• Phase: Phase 4
• First received: October 18, 2010
• Last updated: October 26, 2016
• Start date: April 2010
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 125
• Est. completion date: September 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Bypass Grafting

Intervention

Device:
• Paclitaxel eluting stent
Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	Boston Scientific Corporation, Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	1-First occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization over the duration of follow-up.		60 months	No
Secondary	2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome.		60 months	No
Secondary	3-Total medical costs (at index hospitalization and at follow-up).		60 months	No
Secondary	4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented.		60 months	No
Secondary	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	No
Secondary	6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up.		60 months	Yes
Secondary	7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria.		60 months	Yes