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Vein External Support Trial (VEST)

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ClinicalTrials.gov Identifier: NCT01415245
Recruitment Status : Completed
First Posted : August 11, 2011
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Vascular Graft Solutions Ltd.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Heart Disease Device: Fluent (VGS Fluent external support device) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Vein External Support Trial
Study Start Date : October 2011
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT01415245


Locations
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United Kingdom
Royal Brompton Hospital
London, United Kingdom
Harefield Hospital
Middlesex, United Kingdom
The John Radcliffe Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Vascular Graft Solutions Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Vascular Graft Solutions Ltd.
ClinicalTrials.gov Identifier: NCT01415245    
Other Study ID Numbers: CI-01-01
First Posted: August 11, 2011    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases