9 Months Extension Study of SOMVC001 Study (GALA) Vascular Conduit Preservation Solution

NCT ID: NCT02774824

Last Updated: 2018-01-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 53 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-01
• Study Completion Date: 2017-08-24

Brief Summary

This is a 9-months extension to the following study, protocol number: 003-03: "A study to evaluate the use of SOMVC001 (GALA) vascular conduit preservation solution in patients undergoing coronary artery bypass grafting (GABG)". Participation is allowed exclusively to participants enrolled in the main protocol SOMVC001 (GALA).

Detailed Description

Patients enrolled in this 9-months extension study of SOMVC001 (GALA) will be contacted by phone twice: 6 months and 9 months after a coronary artery bypass graft (CABG) surgery. During these phone call visits and at twelve months post CABG surgery, adverse events and/or concomitant medication changes will be collected from the participant. Twelve months after the CABG surgery procedure, imaging will be performed using 64-slice or better MDCT-scan angiography. The study participation ends at this MDCT-scan visit.

In detail, will be recorded incidence of composite safety outcomes consisting of Major Adverse Cardiac Events (MACE) (death, myocardial infarction [MI], and repeat revascularization), angina, arrhythmias, shortness of breath [SOB], decreased lumen change, graft occlusion and significant stenosis based on Fitzgibbon's scale B and O, following CABG surgery.

Patients in this study are their own control; they receive two SVG; one exposed to GALA and the other exposed to heparinized dose saline. The effect of treatment (GALA vs. Saline) will be evaluated on paired grafts within-person. Therefore, treatment effect will be presented by graft and not by patient. Only adverse clinical events will be presented by patient including their potential relationship to the study product.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

CABG patients from protocol 003-03

Patients who will agree to be followed for an additional 9 months, which include:

2 phone calls at 6 and 9 months after coronary artery bypass graft surgery

1 clinic visit at 12 months after coronary artery bypass graft surgery ( 64-slice or better MDCT angiography)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• patients from protocol #003-03 who agree to be followed for an additional 9 months by signing informed consent.

Exclusion Criteria

• patients who have a contraindication to undergo MDCT angiography ant 12 months post CABG surgery.

• 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 Thoracic Surgeon

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Louis P Perrault, MD, PhD

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

003-10

Identifier Type: -

Identifier Source: org_study_id