9 Months Extension Study of SOMVC001 Study (GALA) Vascular Conduit Preservation Solution
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT02774824
- Lead Sponsor
- Perrault Louis P.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 53
- patients from protocol #003-03 who agree to be followed for an additional 9 months by signing informed consent.
- patients who have a contraindication to undergo MDCT angiography ant 12 months post CABG surgery.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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) . At twelve months following CABG surgery performing a 64-slice or better multi-detector computed tomography (MDCT) angiography, by assessing the magnitude of change in the mean lumen diameter of paired grafts within person, one year post- surgery.
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). At twelve months following CABG surgery Performing a 64-slice or better multi-detector computed tomography (MDCT) angiography by assessing the magnitude of change at maximum stenosis of paired grafts within person, one year post-surgery.
The incidence of vein graft thrombosis will be measured as total graft occlusion At twelve months following CABG surgery Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
- Secondary Outcome Measures
Name Time Method The change in maximal stenosis will be measured and expressed in millimeter (mm) as changes over time. from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
The change in lumen will be measured and expressed in millimeter (mm) as changes over time. from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery. Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
The change in vessel diameter will be measured and expressed in millimeter (mm) as changes over time. from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
The change in total wall thickness will be measured and expressed in millimeter (mm) as changes over time. from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
Trial Locations
- Locations (1)
Montreal Heart Institute
🇨🇦Montreal, Quebec, Canada