Back to results

Evaluation of EndoRefix Endovascular Delivery System and Staple (EndoRefix)

Primary Purpose

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

Status

Withdrawn

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

EndoRefix

About this trial

This is an interventional treatment trial for AAA Graft Implant for Primary Aneurysm Treatment focused on measuring Abdominal Aortic Aneurysm

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

University of Alabama Birmingham
Arizona Heart Hospital
Emory University Hospital
Mary Hitchcock Memorial Hospital
Mount Sinai Hospital
St. Paul University Hospital
St. Lukes Episcopal Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

Endorefix

Arm Description

Evaluation of EndoRefix Endovascular Delivery System and Staple

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00668681

First Posted

April 25, 2008

Last Updated

October 15, 2012

Sponsor

Lombard Medical

1. Study Identification

Unique Protocol Identification Number

NCT00668681

Brief Title

Evaluation of EndoRefix Endovascular Delivery System and Staple

Acronym

EndoRefix

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Withdrawn

Why Stopped

Company business decision, IDE closed, no commercialization planned

Study Start Date

April 2008 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

February 2009 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lombard Medical

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endorefix

Arm Type

Active Comparator

Arm Description

Evaluation of EndoRefix Endovascular Delivery System and Staple

Intervention Type

Device

Intervention Name(s)

EndoRefix

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials: