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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02272582 |
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Date of registration:
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15/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS)
GALA |
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Scientific title:
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A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Grafting (CABG) |
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Date of first enrolment:
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September 24, 2014 |
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Target sample size:
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100 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02272582 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Louis P Perrault, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Montreal Heart Institute |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient is to undergo primary, multi-vessel CABG with at least two saphenous vein
grafts (SVGs)
Exclusion Criteria:
- Patient has in-situ Internal Mammary Artery graft(s) (IMA) only, (no SVG or free
arterial grafts)
- Patients has had prior CABG or planned concomitant valve surgery or aortic aneurysm
repair.
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Coronary Artery Disease
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Intervention(s)
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Device: SOMVC001 Vascular Conduit Solution
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Other: Standard of care Heparin-dosed saline
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Primary Outcome(s)
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Mean wall thickness of paired grafts within 100 participants measured at 4-6 weeks and 3 months post-CABG surgery using 64-slice multidetector computed tomography (MDCT) angiography.
[Time Frame: 4-6 weeks to 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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