AAA Graft Implant for Primary Aneurysm Treatment, AAA Graft Repair to Extend Life of Implant
Conditions
Keywords
Abdominal Aortic Aneurysm
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 for implantation of a staple during endovascular graft procedures.
Interventions
DEVICEEndoRefix
Sponsors
Lombard Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female \>21 years of age 2. Undergoing endovascular stent grafting for AAA repair 3. Post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak.
Exclusion criteria
1. Pregnant 2. Religious, cultural or other objection to the receipt of blood, or blood products. 3. Unwilling to comply with follow-up schedule 4. Unwillingness, or inability to provide informed consent to both trila and procedure 5. Ruptured Aneurysm 6. Area where staple is to be placed has significant loose thrombus associated with it 7. Acute or chronic aortic dissection or mycotoc aneurysm 8. Allergy to device materials 9. Allergy to or intolerance to use of contrast media or cannot be exposed to suitable remedial treatment such as steroids and/or diphenhydramine. 10. Clinically and morbidly obese such that imaging would be severely adversely affected. 11. Uncorrectable bleeding abnormality 12. Inflammatory aneurysm 13. Connective tissue disease (e.g., Marfans syndrome, Ehlers Danlos syndrome) 14. Patients with PTFE grafts 15. Patients with investigational grafts (i.e., those grafts that are not FDA approved)
Countries
United States
Outcome results
None listed