Status:
WITHDRAWN
Evaluation of EndoRefix Endovascular Delivery System and Staple
Lead Sponsor:
Lombard Medical
Conditions:
AAA Graft Implant for Primary Aneurysm Treatment
AAA Graft Repair to Extend Life of Implant
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
This study is intended to provide data to verify safe delivery of a staple previously intended for use in open surgical procedures. A newly modified delivery system will provide endovascular access fo...
Eligibility Criteria
Inclusion
- Male or female \>21 years of age
- Undergoing endovascular stent grafting for AAA repair
- Post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak.
Exclusion
- Pregnant
- Religious, cultural or other objection to the receipt of blood, or blood products.
- Unwilling to comply with follow-up schedule
- Unwillingness, or inability to provide informed consent to both trila and procedure
- Ruptured Aneurysm
- Area where staple is to be placed has significant loose thrombus associated with it
- Acute or chronic aortic dissection or mycotoc aneurysm
- Allergy to device materials
- Allergy to or intolerance to use of contrast media or cannot be exposed to suitable remedial treatment such as steroids and/or diphenhydramine.
- Clinically and morbidly obese such that imaging would be severely adversely affected.
- Uncorrectable bleeding abnormality
- Inflammatory aneurysm
- Connective tissue disease (e.g., Marfans syndrome, Ehlers Danlos syndrome)
- Patients with PTFE grafts
- Patients with investigational grafts (i.e., those grafts that are not FDA approved)
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00668681
Start Date
April 1 2008
End Date
February 1 2009
Last Update
October 17 2012
Active Locations (7)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
2
Arizona Heart Hospital
Phoenix, Arizona, United States, 85006
3
Emory University Hospital
Atlanta, Georgia, United States, 30368
4
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, United States, 03756