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Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents (VELETI II)
This study has been terminated.
(The trial was prematurely stopped due to slow patient enrolment.)
Sponsor:
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Collaborators:
Boston Scientific Corporation
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier:
NCT01223443
First received: October 18, 2010
Last updated: October 26, 2016
Last verified: October 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Coronary Artery Bypass Grafting | Device: Paclitaxel eluting stent | Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Coronary Artery Bypass Surgery
Drug Information available for:
Paclitaxel
U.S. FDA Resources
Further study details as provided by Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:
Primary Outcome Measures:
- 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. [ Time Frame: 60 months ]
Secondary Outcome Measures:
- 1-First occurrence of the composite of cardiac death, myocardial infarction or coronary revascularization over the duration of follow-up. [ Time Frame: 60 months ]
- 2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome. [ Time Frame: 60 months ]
- 3-Total medical costs (at index hospitalization and at follow-up). [ Time Frame: 60 months ]
- 4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented. [ Time Frame: 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. [ Time Frame: 60 months ]
- 6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up. [ Time Frame: 60 months ]
- 7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria. [ Time Frame: 60 months ]
| Enrollment: | 125 |
| Study Start Date: | April 2010 |
| Study Completion Date: | September 2016 |
| Primary Completion Date: | August 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PCI-stenting
Stenting the moderate SVG lesion with the paclitaxel stent
|
Device: Paclitaxel eluting stent
Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment
|
| No Intervention: Standard medical treatment |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- Patient < 18 years old
- Ejection fraction < 30%
- Renal insufficiency with creatinine > 200 μmol/l
- 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
- Presence of more than 2 SVGs with moderate SVG stenoses
- 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)
- Any significant complication occurring during the angioplasty of the culprit lesion(s) during the same procedure
- SVG lesion located at the distal anastomosis
- SVG lesions located at the proximal anastomosis (lesion length < 5 mm from the SVG ostium)
- Lesion length >25 mm
- SVGs ≤ 3 years ago
- Cardiogenic shock
- Remaining coronary or SVG lesion(s) with treatment (PCI or CABG) planned within the following year
- Pregnancy
- Contraindication to aspirin and/or thienopyridine/ticagrelor treatment
- Allergy to paclitaxel
- Any disease with a limiting life-expectancy (less than 2 years)
- Need for chronic anticoagulation treatment
- Definite presence or high suspicion of thrombus or ulceration in the target lesion
- 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
- Vein graft diameter < 2.5 mm
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223443
Please refer to this study by its ClinicalTrials.gov identifier: NCT01223443
Locations
| Canada | |
| Institut universitaire de cardiologie et de pneumologie de Québec | |
| Quebec, Canada, G1V 4G5 | |
Sponsors and Collaborators
Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Boston Scientific Corporation
Canadian Institutes of Health Research (CIHR)
Investigators
| Principal Investigator: | Josep Rodes-Cabau, MD | Institut universitaire de cardiologie et de pneumologie de Québec |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Josep Rodes-Cabau, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec |
| ClinicalTrials.gov Identifier: | NCT01223443 History of Changes |
| Other Study ID Numbers: |
VELETI II |
| Study First Received: | October 18, 2010 |
| Last Updated: | October 26, 2016 |
Keywords provided by Josep Rodes-Cabau, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec:
|
Coronary Artery Bypass Grafting Drug Eluting Stent Saphenous Vein Graft |
Additional relevant MeSH terms:
|
Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents |
Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 21, 2017