Status:
COMPLETED
A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS)
Lead Sponsor:
Perrault Louis P.
Collaborating Sponsors:
Montreal Heart Institute
Somahlution LLC
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
A prospective randomized, double-blinded, comparative within-person study to evaluate the use of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.
Detailed Description
Saphenous vein (SV) harvesting will be performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient t...
Eligibility Criteria
Inclusion
- Patient is to undergo primary, multi-vessel CABG with at least two saphenous vein grafts (SVGs)
Exclusion
- 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.
Key Trial Info
Start Date :
September 24 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02272582
Start Date
September 24 2014
End Date
December 22 2016
Last Update
January 12 2018
Active Locations (1)
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1
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8