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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2014 by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec.
Recruitment status was  Active, not recruiting
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
ClinicalTrials.gov Identifier:
NCT01223443
First received: October 18, 2010
Last updated: May 13, 2014
Last verified: February 2014
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • 2-Cardiac death and myocardial infarction; repeat revascularization; and hospitalization due to an acute coronary syndrome. [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • 3-Total medical costs (at index hospitalization and at follow-up). [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • 4-Costs per major adverse cardiac event (cardiac death, myocardial infarction, revascularization) prevented. [ Time Frame: 60 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 6-Major bleeding complications defined according to the REPLACE-II criteria over the duration of follow-up. [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
  • 7-Stent thrombosis defined and classified according to the Academic Research Consortium criteria. [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
Enrollment: 125
Study Start Date: October 2010
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (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)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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

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

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: May 13, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by 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 27, 2016