- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02774824
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)
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, J0N 1P0
- Montreal Heart Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
CABG patients from protocol 003-03
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) |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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) .
Time Frame: 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.
|
At twelve months following CABG 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).
Time Frame: 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.
|
At twelve months following CABG surgery
|
The incidence of vein graft thrombosis will be measured as total graft occlusion
Time Frame: At twelve months following CABG surgery
|
Using a 64-slice or better multi-detector computed tomography (MDCT) angiography.
|
At twelve months following CABG surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The change in maximal stenosis will be measured and expressed in millimeter (mm) as changes over time.
Time Frame: 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.
|
from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
|
The change in lumen will be measured and expressed in millimeter (mm) as changes over time.
Time Frame: 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.
|
from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery.
|
The change in vessel diameter will be measured and expressed in millimeter (mm) as changes over time.
Time Frame: 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.
|
from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
|
The change in total wall thickness will be measured and expressed in millimeter (mm) as changes over time.
Time Frame: 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.
|
from 4-6 weeks to 12 months and from 3 months to 12 months following CABG surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Louis P Perrault, MD, PhD, Montreal Heart Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 003-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coronary Artery Disease
-
Elixir Medical CorporationIstituto Clinico HumanitasActive, not recruitingCoronary Artery Disease | Chronic Total Occlusion of Coronary Artery | Multi Vessel Coronary Artery Disease | Bifurcation of Coronary Artery | Long Lesions Coronary Artery DiseaseItaly
-
Fundación EPICActive, not recruitingCoronary Artery Disease | Left Main Coronary Artery Disease | Left Main Coronary Artery Stenosis | Restenosis, CoronarySpain
-
Peking Union Medical College HospitalRecruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
Peking Union Medical College HospitalNot yet recruitingCoronary Artery Disease | Inflammation | Coronary Artery Disease Progression | Coronary Artery Stenosis | Coronary Artery Restenosis | Inflammatory Disease | Inflammation VascularChina
-
IGLESIAS Juan FernandoUniversity of BernNot yet recruiting
-
National Institutes of Health Clinical Center (CC)National Heart, Lung, and Blood Institute (NHLBI)CompletedCoronary Arteriosclerosis | Coronary Artery Disease (CAD) | Obstructive Coronary Artery DiseaseUnited States
-
Barts & The London NHS TrustImperial College London; Brunel UniversityNot yet recruitingCORONARY ARTERY DISEASE
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Chronic Total Occlusion of Coronary Artery | Coronary Restenosis | Coronary Artery Stenosis | Coronary Artery RestenosisBelgium
-
Fundación EPICRecruitingCoronary Artery Disease | Coronary Disease | Coronary Occlusion | Left Main Coronary Artery Disease | Coronary Artery StenosisSpain
-
San Luigi Gonzaga HospitalRecruitingCoronary Disease | STEMI | Coronary Artery Ectasia | Right Coronary Artery Occlusion | Right Coronary Artery StenosisSpain, Italy