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

Sperimentale: SOMVC001 Vascular Conduit Solution

Each patient will serve as his/her own control because each patient will have two graft segments with one segment immersed in SOMVC001 and the other in heparin dosed saline (Standard solution). Patients will be randomized using a simple random sample allocation scheme. At the time of randomization, patients will be assigned an allocation number. Each randomized patient will be implanted with two SVGs, alternating Target Region A (Circumflex or Diagonal) and Target Region B (Right Coronary System or Diagonal) and alternating (proximal vs. distal) segments of the harvested SV. A randomization schedule will be developed to ensure appropriate randomization allocation of the harvested vein segment being grafted to the targeted regions.

Dispositivo: 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.

Comparatore attivo: Standard of Care Heparin-dosed saline

Each patient will serve as his/her own control because each patient will have two graft segments with one segment immersed in SOMVC001 and the other in heparin dosed saline (Standard solution). Patients will be randomized using a simple random sample allocation scheme. At the time of randomization, patients will be assigned an allocation number. Each randomized patient will be implanted with two SVGs, alternating Target Region A (Circumflex or Diagonal) and Target Region B (Right Coronary System or Diagonal) and alternating (proximal vs. distal) segments of the harvested SV. A randomization schedule will be developed to ensure appropriate randomization allocation of the harvested vein segment being grafted to the targeted regions.

Altro: 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.

Altri nomi:

• comparatore attivo

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.