Evaluation of EndoRefix Endovascular Delivery System and Staple

Lombard Medical

Status

Withdrawn

Conditions

AAA Graft Repair to Extend Life of Implant

AAA Graft Implant for Primary Aneurysm Treatment

Treatments

Device: EndoRefix

Study type

Interventional

Funder types

Industry

Identifiers

NCT00668681

Endo060234

Details and patient eligibility

About

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.

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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)