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The trial was prematurely stopped due to slow patient enrolment.
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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCI-stenting | Experimental | Stenting the moderate SVG lesion with the paclitaxel stent |
|
| Standard medical treatment | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paclitaxel eluting stent | Device | Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep Rodes-Cabau, MD | Institut universitaire de cardiologie et de pneumologie de Québec, University Laval | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut universitaire de cardiologie et de pneumologie de Québec | Québec | Quebec | G1V 4G5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27815344 | Derived | 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. |
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| 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 |
| 6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up. | 60 months |
| 7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria. | 60 months |