Clinical trial NCT00668681: Evaluation of EndoRefix Endovascular Delivery System and Staple
Official title: Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: AAA Graft Implant for Primary Aneurysm Treatment
AAA Graft Repair to Extend Life of Implant
Keywords: Abdominal Aortic Aneurysm
Lead sponsor: Lombard Medical
Sponsor class: INDUSTRY
First posted: 2008-04-29
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Hospital
state: Arizona
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Lebanon
country: United States
facility: Mary Hitchcock Memorial Hospital
state: New Hampshire
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Dallas
country: United States
facility: St. Paul University Hospital
state: Texas
city: Houston
country: United States
facility: St. Lukes Episcopal Hospital
state: Texas
Study officials:
affiliation: St. Paul University Hospital, Dallas Texas
name: Frank Arko, MD
role: STUDY_CHAIR
affiliation: Mount Sinai Hospital, New York
name: Peter Faries, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barnes Jewish Hospital, St. Louis Missouri
name: Louis Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Arizona Heart Institute, Phoenix, Arizona
name: Venkatash Ramaiah, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Medical Center
name: Mark Mewissen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mary Hitchcock Memorial Hospital, Lebanon New Hampshire
name: Mark Fillinger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Lukes Episcopal Hospital, Houston Texas
name: Zvonko Krajcer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama, Birmingham Alabama.
name: Will Jordan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida, Gainesville, Florida
name: Anthony Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University, Atlanta Georgia
name: Karthikes Kasirajan, MD
role: PRINCIPAL_INVESTIGATOR
References: