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

Perrault Louis P.

Status: Completed

Conditions: Coronary Artery Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02774824

003-10

Details and patient eligibility

About

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).

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

53 participants in 1 patient group

CABG patients from protocol 003-03

Description:

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)