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VEST Venous Graft External Support Pivotal Study (VEST Pivotal)

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ClinicalTrials.gov Identifier: NCT03209609
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : June 29, 2018
Sponsor:
Collaborator:
International Center for Health Outcomes and Innovation Research
Information provided by (Responsible Party):
Vascular Graft Solutions Ltd.

Brief Summary:
Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: VEST Procedure: Coronary artery bypass vein grafts Not Applicable

Detailed Description:

Clinical significance:

Coronary artery bypass grafting (CABG) remains the gold standard treatment for patients with multi-vessel coronary artery disease. Despite the proposed benefits of multiple arterial grafts, autologous saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. Progressive SVG failure after CABG remains a key limitation to the long-term success of surgery.

Objective:

Coronary artery bypass grafting (CABG) remains the gold standard treatment for patients with multi-vessel coronary artery disease. Despite the proposed benefits of multiple arterial grafts, autologous saphenous vein grafts (SVGs) are still the most frequently used bypass conduits in CABG. Progressive SVG failure after CABG remains a key limitation to the long-term success of surgery.

Study design:

Prospective, multi-center, randomized, within-subject-controlled , trial, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo SVG CABG with arterial grafting of IMA to LAD and two or more saphenous vein grafts. In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control. Thus, the full cohort will provide a basis for comparison between two sets of SVGs: A VEST supported set; and an unsupported set.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: In each patient, one SVG bypass will be randomized to be supported by the VEST, while another will not be supported and serve as control.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VEST supported vein graft
Coronary artery bypass vein graft supported with the VEST implant
Device: VEST
External support for vein grafts, cobalt chrome braid

Procedure: Coronary artery bypass vein grafts
Bypass coronary arteries with autologous saphenous vein grafts

Active Comparator: Standard of care vein grafts
Coronary artery bypass vein grafts
Procedure: Coronary artery bypass vein grafts
Bypass coronary arteries with autologous saphenous vein grafts




Primary Outcome Measures :
  1. Intimal hyperplasia area/graft occlusion [ Time Frame: 1 year ]
    Intimal hyperplasia (plaque+media) area [mm2] as assessed by IVUS at 12 months. Occluded vessels are accounted for in the analysis of the primary endpoint


Secondary Outcome Measures :
  1. Lumen diameter uniformity [ Time Frame: 1 year ]
    Lumen diameter uniformity, assessed by angiography for each graft separately and expressed by the Fitzgibbon classification (22), on a 3-point ordinal scale

  2. vein graft failure [ Time Frame: 1 year ]
    Graft Failure (≥50% stenosis) by cardiac angiography


Other Outcome Measures:
  1. MACCE [ Time Frame: annually over 5 years ]
    Major adverse cardiac and cerebrovascular events



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation.
  2. Age 21 years or older.
  3. Planned and scheduled on-pump CABG.
  4. Two or more vein grafts: 1 for the right coronary artery, 1 or more for the left coronary arteries, with native vessels having at least 75% stenosis.
  5. IMA graft indicated for the LAD and additional arterial graft considered based on practice guidelines. A patient who is candidate for one, two, or more arterial grafts would only be eligible if in addition to the arterial grafts at least two vein grafts are used as specified above.
  6. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed (without significant distal stenosis), as assessed by pre-operative cardiac angiography.

Exclusion Criteria:

  1. Concomitant non-CABG cardiac surgical procedure.
  2. Prior cardiac surgery.
  3. Emergency CABG surgery (cardiogenic shock, inotropic pressure support, IABP).
  4. Contraindication for on-pump CABG with cardioplegic arrest (e.g., severely calcified aorta).
  5. Calcification at the intended anastomotic sites, as assessed upon opening of the chest and before randomization.
  6. Severe vein varicosity as assessed after vein harvesting and before randomization.
  7. History of clinical stroke within 3 months prior to randomization.
  8. Severe renal dysfunction (Cr>2.0 mg/dL).
  9. Documented or suspected untreated diffuse peripheral vascular disease such as: carotid stenosis or claudication of the extremities.
  10. Concomitant life-threatening disease likely to limit life expectancy to less than two years.
  11. Inability to tolerate or comply with required guideline-based post-operative drug regimen (antiplatelet plus statin) and/or inability to take aspirin.
  12. Inability to comply with required follow-ups including angiographic imaging methods (e.g. contrast allergy).
  13. Concurrent participation in an interventional (drug or device) trial.

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): NCT03209609


Contacts
Contact: Orit Yarden, PhD +972 54 3073050 orit@graftsolutions.com
Contact: Mary Beth Marks, RN, BSN 212-659-9699 mary.marks@mountsinai.org

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Edward Lozano    626-200-3873    edwardlo@med.usc.edu   
Principal Investigator: Michael Bowdish, MD         
United States, Indiana
Lutheran Hospital of Indiana Recruiting
Fort Wayne, Indiana, United States, 46804
Contact: Sharon Eichman, RN    260-458-3579    SEichman@Lutheran-Hosp.com   
Principal Investigator: Joseph Ladowski, MD         
United States, Maryland
University of Maryland Baltimore Recruiting
Baltimore, Maryland, United States, 21201
Contact: John Treffalls    410-328-9409    JATreffalls@som.umaryland.edu   
Principal Investigator: Bradley Taylor, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Brandon Dunagan    507-255-7566    Dunagan.Brandon@mayo.edu   
Principal Investigator: Juan A Crestanello, MD         
United States, New Hampshire
Dartmouth-Hitchcock Medical Center Recruiting
Lebanon, New Hampshire, United States, 03756
Contact: Henry Stokes, RN    603-650-6134    Henry.C.Stokes@hitchcock.org   
Principal Investigator: Alexander Iribarne, MD, MS         
United States, New York
Mount Sinai St Luke's Recruiting
New York, New York, United States, 10025
Contact: Miguel Bravo    210 331-6651    Miguel.Bravo@mountsinai.org   
Principal Investigator: John D Puskas, MD, FACC, FACS         
New York Presbyterian Hospital/Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Lyn Goldsmith, MA,RN,BSN    212-342-0261    lg2240@cumc.columbia.edu   
Principal Investigator: Micahel Argenziano, MD, FACS         
Montefiore Medical Center Recruiting
New York, New York, United States, 10467
Contact: Magdalena Mamczur-Madry, RN, BSN, MS    718-920-3576    mmamczur@montefiore.org   
Principal Investigator: Daniel Goldstein, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary Lou Mayer, RN, BSN    215-662-7981    Marylou.mayer@uphs.upenn.edu   
Principal Investigator: Michael A Acker, MD         
United States, Texas
Baylor Scott & White Research Institute, The Heart Hospital Baylor Plano Recruiting
Plano, Texas, United States, 75093
Contact: Heath Shirkey, RN, BSN, CCRP    469-814-4185    Heath.Shirkey@BSWHealth.org   
Principal Investigator: Michael DiMaio, MD         
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: China Green    434-243-2747    CJG8P@hscmail.mcc.virginia.edu   
Contact: Mike J Cosner    434-982-6003 ext 3523    JMC2CM@hscmail.mcc.virginia.edu   
Principal Investigator: Gorav Ailawadi, MD         
Canada, Quebec
Institut de Cardiologie de Montréal Recruiting
Montréal, Quebec, Canada, H1T 1C8
Contact: Sophie Robichaud    514-376-3330 ext 3305    Sophie.robichaud@icm-mhi.org   
Principal Investigator: Louis Perrault, MD         
Institut Universitaire de Cardiologie et de Pneumologie de Québec - Université Laval Recruiting
Québec City, Quebec, Canada, G1V 4G5
Contact: Hugo Tremblay    418-656-8711 ext 3797    hugo.tremblay@criucpq.ulaval.ca   
Contact: Nathalie Gagné    418 656-8711 ext 2645    nathalie.gagne@criucpq.ulaval.ca   
Principal Investigator: Pierre Voisine, MD         
Sponsors and Collaborators
Vascular Graft Solutions Ltd.
International Center for Health Outcomes and Innovation Research
Investigators
Principal Investigator: John Puskas, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Daniel Goldstein, MD Montefiore Medical Center

Responsible Party: Vascular Graft Solutions Ltd.
ClinicalTrials.gov Identifier: NCT03209609     History of Changes
Other Study ID Numbers: CD0131
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by Vascular Graft Solutions Ltd.:
Coronary artery bypass

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases