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VEST Venous Graft External Support Pivotal Study (VEST Pivotal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209609
Recruitment Status : Active, not recruiting
First Posted : July 6, 2017
Last Update Posted : March 1, 2019
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.

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Study Type : Interventional  (Clinical Trial)
Actual 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

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, Learn About Clinical Studies.


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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 to native vessels having at least 75% stenosis and comparable runoff.
  5. IMA graft indicated for the LAD. Additional arterial grafts may be considered based on practice guidelines.
  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 and verified by diameter gauging intraoperatively.

Exclusion Criteria:

  1. Concomitant non-CABG cardiac surgical procedure.
  2. Prior cardiac surgery.
  3. Emergency CABG surgery.
  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


Locations
Show Show 17 study locations
Sponsors and Collaborators
Vascular Graft Solutions Ltd.
International Center for Health Outcomes and Innovation Research
Investigators
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Principal Investigator: John Puskas, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Daniel Goldstein, MD Montefiore Medical Center

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Responsible Party: Vascular Graft Solutions Ltd.
ClinicalTrials.gov Identifier: NCT03209609    
Other Study ID Numbers: CD0131
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Vascular Graft Solutions Ltd.:
Coronary artery bypass
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases