Evaluation of EndoRefix Endovascular Delivery System and Staple

AAA Graft Implant for Primary Aneurysm Treatment Clinical Trial

— EndoRefix  

Official title:

Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00668681
• Other study ID #: Endo060234
• Status: Withdrawn
• Phase: N/A
• First received: April 25, 2008
• Last updated: October 15, 2012
• Start date: April 2008
• Est. completion date: February 2009

Study information

• Verified date: October 2012
• Source: Lombard Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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)

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AAA Graft Implant for Primary Aneurysm Treatment
• AAA Graft Repair to Extend Life of Implant

Intervention

Device:
• EndoRefix

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Lombard Medical

Country where clinical trial is conducted

United States,