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

A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Grafting (CABG)

A prospective randomized, double-blinded, comparative within-person study to evaluate the use of SOMVC001 vs. heparin dosed saline in patients undergoing CABG.

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: SOMVC001 Vascular Conduit Solution; Other: Standard of care Heparin-dosed saline

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H1T 1C8
      • Montreal Heart Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Active Comparator: 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.	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.; Other Names: active comparator

What is the study measuring?

Primary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Perrault Louis P.
• Collaborators: Montreal Heart Institute; Somahlution LLC
• Investigators: Principal Investigator: Louis P Perrault, MD, Montreal Heart Institute

Publications and helpful links

General Publications

• Ben Ali W, Voisine P, Olsen PS, Jeanmart H, Noiseux N, Goeken T, Satishchandran V, Cademartiri F, Cutter G, Veerasingam D, Brown C, Emmert MY, Perrault LP. DuraGraft vascular conduit preservation solution in patients undergoing coronary artery bypass grafting: rationale and design of a within-patient randomised multicentre trial. Open Heart. 2018 Apr 13;5(1):e000780. doi: 10.1136/openhrt-2018-000780. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2014
• Primary Completion (Actual): December 22, 2016
• Study Completion (Actual): December 22, 2016

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Actual): January 12, 2018
• Last Update Submitted That Met QC Criteria: January 10, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: 003-03