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Clinical Trials/ACTRN12613000707763
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Withdrawn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.

Mobius Medical Pty Ltd0 sites25 target enrollmentJune 28, 2013

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Withdrawn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.

Registry
who.int
Start Date
June 28, 2013
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional
Sex
All

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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