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

Conditions

Coronary Artery Disease

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 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. Imaging, using 64-slice or better MDCT, will be completed 4-6 weeks and 3 months post surgery (CABG) procedure.

Etem Caliskan, Sigrid Sandner, Martín Misfeld, José I. Aramendi, Sacha P. Salzberg et al. (11 authors)

Journal of Cardiothoracic Surgery2019-10-1521 citations

10.1186/s13019-019-1010-z

DuraGraft vascular conduit preservation solution in patients undergoing coronary artery bypass grafting: rationale and design of a within-patient randomised multicentre trial

Walid Ben Ali, Pierre Voisine, Peter Skov Olsen, Hugues Jeanmart, Nicolas Noiseux et al. (13 authors)

Open Heart2018-04-0115 citations

10.1136/openhrt-2018-000780

Interventions

DEVICESOMVC001 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.

OTHERStandard 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.

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
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.	4-6 weeks to 3 months

Countries

Canada

Outcome results

None listed