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VEST III PMS Clinical Protocol (VEST III)

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ClinicalTrials.gov Identifier: NCT02511834
Recruitment Status : Active, not recruiting
First Posted : July 30, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Vascular Graft Solutions Ltd.

Brief Summary:
Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective, multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the right territory and one or more SVGs to the left territory. Of all vein grafts, one will be selected randomly to receive treatment with VEST and another designated Control.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Device: VEST External Support Procedure: Coronary Artery Bypass Surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : October 19, 2015
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : April 2019

Arm Intervention/treatment
Experimental: VEST supported
Vein graft supported by VEST
Device: VEST External Support
Procedure: Coronary Artery Bypass Surgery
Other Name: CABG

Active Comparator: Control
Vein grafts unsupported by VEST
Procedure: Coronary Artery Bypass Surgery
Other Name: CABG




Primary Outcome Measures :
  1. Proportion of Vein grafts with Fitzgibbon I patency score out of all grafts including occluded ones. [ Time Frame: 2 years ]
    Perfect patency, no lumen irregularities. Rates out of all grafts including occluded ones.


Secondary Outcome Measures :
  1. Vein graft failure [ Time Frame: 2 years ]
    Defined as ≥50% stenosis by QCA

  2. Early vein graft failure [ Time Frame: 6 months ]
    Early vein graft failure, defined as >50% occlusion by CT Angio



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient scheduled for on-pump CABG on clinical grounds
  2. Two or more bypass vein grafts bypasses indicated as follows: one (1) for right coronary artery, 1 or more for left coronary arteries and IMA indicated for the LAD on clinical grounds
  3. Appropriately sized and accessible target coronary arteries, with a minimum diameter of 1.5 mm and adequate vascular bed
  4. Ability to give their informed written consent
  5. Ability and willingness to comply with study follow up requirements
  6. Patient is ≥ 18 and ≤ 80 years of age, and has Life expectancy ≥5 years

Exclusion Criteria:

  1. Concomitant non-CABG cardiac 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, before randomization
  6. Severe vein varicosity
  7. Prior debilitating stroke less than 1 year before surgery
  8. Severe renal dysfunction (Cr>2.0 mg/dL or >177 μmol/L)
  9. Women of child bearing age
  10. Concomitant life-threatening disease likely to limit life expectancy to less than 5 years
  11. Indication for Warfarin up to time of surgery
  12. Inability to tolerate or comply with required normal post-operative drug regimen (antiplatelet, statin and beta-blockers) that cannot adequately be controlled.
  13. inability to take aspirin
  14. Contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
  15. Inability to comply with required follow-ups including angiographic and/or CT imaging methods.
  16. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study

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): NCT02511834


Locations
Austria
Medical University of Innsbruck
Innsbruck, Austria
Medical University of Vienna
Vienna, Austria
Germany
German Heart Center
Berlin, Germany
Immanuel Hospital Bernau. Brandenburg Heart Center
Bernau, Germany
University Hospital of Cologne
Cologne, Germany
West-German Heart Center Essen University
Essen, Germany
University Medical Center Schleswig-Holstein
Lübeck, Germany
Krankenhaus der Barmherzigen Bruder
Trier, Germany
Israel
Rambam - Health Care Campus
Haifa, Israel
Sheba Medical Center Hospital
Ramat Gan, Israel
United Kingdom
Papworth Hospital
Papworth Everard, Cambridge, United Kingdom
Blackpool Victoria Hospital
Blackpool, United Kingdom
University Hospitals Bristol
Bristol, United Kingdom
The John Radcliffe Hospital
Oxford, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Sponsors and Collaborators
Vascular Graft Solutions Ltd.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vascular Graft Solutions Ltd.
ClinicalTrials.gov Identifier: NCT02511834     History of Changes
Other Study ID Numbers: CD0113
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018

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