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Vein External Support Trial (VEST)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vascular Grafts Solutions Ltd.
ClinicalTrials.gov Identifier:
NCT01415245
First received: August 10, 2011
Last updated: September 20, 2012
Last verified: September 2012
History of Changes
  Purpose

Prospective, multi-center, randomized, controlled pilot study to demonstrate the safety and effectiveness of the VGS Fluent external support device, supporting saphenous vein grafts in patients with coronary heart disease.


Condition Intervention
Coronary Heart Disease
 Device: Fluent (VGS Fluent external support device)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Vein External Support Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vascular Grafts Solutions Ltd.:

Estimated Enrollment: 30
Study Start Date: October 2011
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Device applied to saphenous vein graft
 Device: Fluent (VGS Fluent external support device)
Fluent external support device applied to saphenous vein graft
No Intervention: Control
Saphenous vein graft without device support

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Primary Inclusion Criteria:

  1. Patient scheduled for on-pump CABG on clinical grounds
  2. Vein grafts indicated for right and circumflex coronary arteries and LIMA indicated for the LAD on clinical grounds
  3. Native circumflex and right coronary arteries have at least one stenosis in each vessel> 75%

Primary Exclusion Criteria:

  1. Concomitant non-CABG cardiac procedure
  2. Prior peripheral vascular or cardiac surgery
  3. Emergency CABG surgery (cardiogenic shock, inotrophic pressure support, IABP)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415245

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom
Harefield Hospital
Middlesex, United Kingdom
The John Radcliffe Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Vascular Grafts Solutions Ltd.
  More Information

No publications provided

Responsible Party: Vascular Grafts Solutions Ltd.
ClinicalTrials.gov Identifier: NCT01415245     History of Changes
Other Study ID Numbers: CI-01-01
Study First Received: August 10, 2011
Last Updated: September 20, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 16, 2013