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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774824
• Other study ID #: 003-10
• Status: Completed
• Phase: N/A
• First received: May 5, 2016
• Last updated: January 9, 2018
• Start date: October 1, 2015
• Est. completion date: August 24, 2017

Study information

• Verified date: January 2018
• Source: Montreal Heart Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 24, 2017
• Est. primary completion date: August 24, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Canada	Montreal Heart Institute	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Perrault Louis P.	Montreal Heart Institute, Somahlution LLC

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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) .	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.	At twelve months following CABG surgery
Primary	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).	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.	At twelve months following CABG surgery
Primary	The incidence of vein graft thrombosis will be measured as total graft occlusion	Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.	At twelve months following CABG surgery
Secondary	The change in maximal stenosis will be measured and expressed in millimeter (mm) as changes over time.	Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.	from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
Secondary	The change in lumen will be measured and expressed in millimeter (mm) as changes over time.	Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.	from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery.
Secondary	The change in vessel diameter will be measured and expressed in millimeter (mm) as changes over time.	Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.	from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
Secondary	The change in total wall thickness will be measured and expressed in millimeter (mm) as changes over time.	Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.	from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery