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Sealing Moderate Coronary Saphenous VEin Graft Lesions With Paclitaxel-Eluting Stents (VELETI II)

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ClinicalTrials.gov Identifier: NCT01223443
Recruitment Status : Terminated (The trial was prematurely stopped due to slow patient enrolment.)
First Posted : October 19, 2010
Last Update Posted : October 27, 2016
Sponsor:
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

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Grafting Device: Paclitaxel eluting stent Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
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
Study Start Date : April 2010
Actual Primary Completion Date : August 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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. 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. 2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome. [ Time Frame: 60 months ]
  3. 3-Total medical costs (at index hospitalization and at follow-up). [ Time Frame: 60 months ]
  4. 4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented. [ Time Frame: 60 months ]
  5. 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. 6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up. [ Time Frame: 60 months ]
  7. 7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria. [ Time Frame: 60 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01223443


Locations
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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
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Principal Investigator: Josep Rodes-Cabau, MD Institut universitaire de cardiologie et de pneumologie de Québec
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Josep Rodes-Cabau, MD, Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
ClinicalTrials.gov Identifier: NCT01223443    
Other Study ID Numbers: VELETI II
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 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:
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Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action