A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS)

NACompletedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

September 24, 2014

Primary Completion Date

December 22, 2016

Study Completion Date

December 22, 2016

Conditions
Coronary Artery Disease
Interventions
DEVICE

SOMVC001 Vascular Conduit Solution

SV harvesting will be uniformly 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 to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.

OTHER

Standard of care Heparin-dosed saline

SV harvesting will be uniformly 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 to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.

Trial Locations (1)

H1T 1C8

Montreal Heart Institute, Montreal

All Listed Sponsors
collaborator

Montreal Heart Institute

OTHER

collaborator

Somahlution LLC

INDUSTRY

lead

Perrault Louis P.

OTHER

NCT02272582 - A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing CABG (STEPS) | Biotech Hunter | Biotech Hunter