Coronary Artery Bypass Grafting Clinical Trial
— VELETI IIOfficial 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
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Institut universitaire de cardiologie et de pneumologie de Québec | Quebec |
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) |
Canada,
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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