None listed
Conditions
Brief summary
Participants are invited to take part in this research project if they are undergoing a coronary artery bypass graft surgery (CABG). During the surgery, blood vessels from other parts of the body will be used to ‘bypass’ blocked blood vessels in the heart which will improve the blood flow to the heart muscle. When blood vessels are removed from the body they must be immersed in a solution (salts in water) to keep them healthy before until they are replaced onto the heart. This research project is testing a new solution known as SOMVC001 (also known as GALA), which is intended to improve the preservation of the blood vessels, which are removed during the operation until they are placed on the heart.
Interventions
Saphenous vein harvesting will be uniformly performed using a standardised vein harvesting procedure. Harvested vein segments will be flushed and immersed in SOMVC001. After being stored in SOMVC001, vein segments will be grafted using standard surgical techniques.
SOMVC001 is a physiological salt solution containing Glutathione, Ascorbic Acid, and L-Arginine. SOMVC001 has nutrients for the cells as well as protective ingredients that can help the cells resist the damaging effects of prolonged
Saphenous vein harvesting will be uniformly performed using a standardised vein harvesting procedure. Harvested vein segments will be flushed and immersed in SOMVC001. After being stored in SOMVC001, vein segments will be grafted using standard surgical techniques. SOMVC001 is a physiological salt solution containing Glutathione, Ascorbic Acid, and L-Arginine. SOMVC001 has nutrients for the cells as well as protective ingredients that can help the cells resist the damaging effects of prolonged storage. Components of SOMVC001 solution: i. Calcium chloride ii. Potassium chloride iii. Potassium phosphate (monobasic) iv. Magnesium chloride (hexahydrate) v. Magnesium sulfate (heptahydrate) vi. Sodium chloride vii. Sodium bicarbonate viii. Sodium phosphate (dibasic; hepatahydrate) ix. D-Dextrose x. Glutathione (reduced) xi. Ascorbic acid xii. L-Arginine xiii. Distilled water
Sponsors
Mobius Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
*Adults age >18 to <75 years *Patients undergoing first time elective or urgent CABG-only procedure *Patients with at least 1 planned SVG *Left ventricular ejection fraction (LVEF) >50% *Female patients must be surgically sterile or postmenopausal *Willingness, ability, and commitment to participate in a follow-up evaluation including a clinic visit at 30 days after the study procedure
Exclusion criteria
* In-situ IMA graft(s) only (no SVG) * Prior CABG or planned concomitant valve surgery or aortic aneurysm repair * Any clinically significant valve disease * Left ventricular ejection fraction (LVEF) <50% * Myocardial Infarction within 2 weeks of screening * Creatinine >177 micro mol/l * Vasculitis or another nonatherosclerotic cause of CAD * Hypercoagulable state * Any condition or disease detected that would render the patient unsuitable for the study * Involvement in another drug or device study within 30 days * Inability of the patient to provide informed consent
Outcome results
None listed