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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01223443
Other study ID # VELETI II
Secondary ID
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


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
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