Clinical trial NCT02774824: 9 Months Extension Study of SOMVC001 Study (GALA) Vascular Conduit Preservation Solution
Official title: A 9-month Extension Study to: A Study to Evaluate the Use of SOMVC001 (GALA) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Grafting (CABG)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Montreal Heart Institute
Sponsor class: OTHER
Collaborators: name: Montreal Heart Institute
name: Somahlution LLC
First posted: 2016-05-17
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had a coronary artery bypass graft surgery (CABG), and took part in previous main study of SOMVC001 (GALA) protocol ID # 003-03 .

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.

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.

Primary outcomes:
measure: It will be measured and reported, the mean lumen diameter of paired grafts (one treated vs one not treated) within-person. Mean lumen diameter will be expressed in millimeter (mm) .
timeFrame: At twelve months following CABG surgery
measure: It will be measured and reported, the maximum stenosis of paired grafts (one treated vs one not treated) within-person. The maximum stenosis will be expressed in millimeter (mm).
timeFrame: At twelve months following CABG surgery
measure: The incidence of vein graft thrombosis will be measured as total graft occlusion
timeFrame: At twelve months following CABG surgery
Secondary outcomes:
measure: The change in maximal stenosis will be measured and expressed in millimeter (mm) as changes over time.
timeFrame: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
measure: The change in lumen will be measured and expressed in millimeter (mm) as changes over time.
timeFrame: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery.
measure: The change in vessel diameter will be measured and expressed in millimeter (mm) as changes over time.
timeFrame: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
measure: The change in total wall thickness will be measured and expressed in millimeter (mm) as changes over time.
timeFrame: from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
Study officials:
affiliation: Montreal Heart Institute
name: Louis P Perrault, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.