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

NCT ID: NCT02272582

Last Updated: 2018-01-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-24
• Study Completion Date: 2016-12-22

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

SOMVC001 Vascular Conduit Solution

Intervention Type: DEVICE

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard of care Heparin-dosed saline

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

active comparator

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Montreal Heart Institute

OTHER

Sponsor Role: collaborator

Somahlution LLC

INDUSTRY

Sponsor Role: collaborator

Perrault Louis P.

OTHER

Sponsor Role: lead

Responsible Party

Perrault Louis P.

Cardiovascular and Thoracic Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Louis P Perrault, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal Heart Institute

Locations

Montreal Heart Institute

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 29682294 (View on PubMed)

Other Identifiers

003-03

Identifier Type: -

Identifier Source: org_study_id