ACTRN12613000707763
Withdrawn
未知
A Study to Evaluate the short term clinical outcomes of GALA (Trademark) Vascular Conduit Preservation Solution in Patients Undergoing Coronary Artery Bypass Graft Surgery.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mobius Medical Pty Ltd
- Enrollment
- 25
- Status
- Withdrawn
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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