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Evaluation of EndoRefix Endovascular Delivery System and Staple

NCT ID: NCT00668681

Last Updated: 2012-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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

Keywords

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Endorefix

Evaluation of EndoRefix Endovascular Delivery System and Staple

Group Type ACTIVE_COMPARATOR

EndoRefix

Intervention Type DEVICE

Interventions

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EndoRefix

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lombard Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Arko, MD

Role: STUDY_CHAIR

St. Paul University Hospital, Dallas Texas

Peter Faries, MD

Role: PRINCIPAL_INVESTIGATOR

Mount Sinai Hospital, New York

Louis Sanchez, MD

Role: PRINCIPAL_INVESTIGATOR

Barnes Jewish Hospital, St. Louis Missouri

Venkatash Ramaiah, MD

Role: PRINCIPAL_INVESTIGATOR

Arizona Heart Institute, Phoenix, Arizona

Mark Mewissen, MD

Role: PRINCIPAL_INVESTIGATOR

St. Luke's Medical Center

Mark Fillinger, MD

Role: PRINCIPAL_INVESTIGATOR

Mary Hitchcock Memorial Hospital, Lebanon New Hampshire

Zvonko Krajcer, MD

Role: PRINCIPAL_INVESTIGATOR

St. Lukes Episcopal Hospital, Houston Texas

Will Jordan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama, Birmingham Alabama.

Anthony Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida, Gainesville, Florida

Karthikes Kasirajan, MD

Role: PRINCIPAL_INVESTIGATOR

Emory University, Atlanta Georgia

Locations

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University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

Arizona Heart Hospital

Phoenix, Arizona, United States

Site Status

Emory University Hospital

Atlanta, Georgia, United States

Site Status

Mary Hitchcock Memorial Hospital

Lebanon, New Hampshire, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

St. Paul University Hospital

Dallas, Texas, United States

Site Status

St. Lukes Episcopal Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Endo060234

Identifier Type: -

Identifier Source: org_study_id