Evaluation of EndoRefix Endovascular Delivery System and Staple

Withdrawn before enrolling · Not applicable

Conditions studied: AAA Graft Implant for Primary Aneurysm Treatment, AAA Graft Repair to Extend Life of Implant

In brief

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 for implantation of a staple during endovascular graft procedures.

Key facts

Study ID

NCT00668681

Run by

Lombard Medical

People needed

0

Starts

2008-04-01

Expected to finish

2009-02-01

Last updated by the study team

2012-10-17

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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)

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States
• Arizona Heart Hospital — Phoenix, Arizona, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Mary Hitchcock Memorial Hospital — Lebanon, New Hampshire, United States
• Mount Sinai Hospital — New York, New York, United States
• St. Paul University Hospital — Dallas, Texas, United States
• St. Lukes Episcopal Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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