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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02774824

Enrollment

Registered

2016-05-17

Start date

2015-10-01

Completion date

2017-08-24

Last updated

2018-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.
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.

Countries

Canada

Outcome results