A Study to Evaluate the Use of GALA (Trademark), a Preservation Solution for Blood Vessels in Patients Undergoing Coronary Artery Bypass Graft Surgery.

Not Applicable

Withdrawn

• Conditions: Preservation of vein grafts in patients undergoing CABG (Coronary Artery Bypass Graft) Surgery; Cardiovascular - Coronary heart disease; Surgery - Other surgery

• Registration Number: ACTRN12613000707763
• Lead Sponsor: Mobius Medical Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified