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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.

Tracking Information
First Submitted Date  ICMJE July 4, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date March 1, 2019
Actual Study Start Date  ICMJE January 9, 2018
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2017)
  • 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
  • vein graft failure [ Time Frame: 1 year ]
    Graft Failure (≥50% stenosis) by cardiac angiography
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 4, 2017)
MACCE [ Time Frame: annually over 5 years ]
Major adverse cardiac and cerebrovascular events
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE VEST Venous Graft External Support Pivotal Study
Official Title  ICMJE A Multi-center, Randomized, Within-subject-controlled, Open Label Study of the Safety and Effectiveness of VEST, Venous External Support
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • Device: VEST
    External support for vein grafts, cobalt chrome braid
  • Procedure: Coronary artery bypass vein grafts
    Bypass coronary arteries with autologous saphenous vein grafts
Study Arms  ICMJE
  • Experimental: VEST supported vein graft
    Coronary artery bypass vein graft supported with the VEST implant
    Interventions:
    • Device: VEST
    • Procedure: Coronary artery bypass vein grafts
  • Active Comparator: Standard of care vein grafts
    Coronary artery bypass vein grafts
    Intervention: Procedure: Coronary artery bypass vein grafts
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 4, 2017)
224
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2024
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209609
Other Study ID Numbers  ICMJE CD0131
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Vascular Graft Solutions Ltd.
Study Sponsor  ICMJE Vascular Graft Solutions Ltd.
Collaborators  ICMJE International Center for Health Outcomes and Innovation Research
Investigators  ICMJE
Principal Investigator: John Puskas, MD Icahn School of Medicine at Mount Sinai
Principal Investigator: Daniel Goldstein, MD Montefiore Medical Center
PRS Account Vascular Graft Solutions Ltd.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP