Skip to main content
OpenTrials
Completed

NCT Number: NCT02774824

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Montreal Heart Institute

Montreal, Quebec, J0N 1P0, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Perrault Louis P.

Other

Collaborators

  • Montreal Heart Institute
  • Somahlution LLC

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 17, 2016
Registry last updated
Jan 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.