Evaluation of EndoRefix Endovascular Delivery System and Staple

This study has been suspended.

Sponsors and Collaborators:	Lombard Medical St. Paul University Hospital, Dallas Texas Arizona Heart Institute Barnes-Jewish Hospital Foundation Mount Sinai Hospital, New York New York St. Lukes Episcopal Hospital, Houston Texas St. Lukes Medical Center, Wilwaukee, Wisconsin Mary Hitchcock Memorial Hospital, Lebanon New Hampshire University of Alabama at Birmingham University of Florida Emory University
Information provided by:	Lombard Medical
ClinicalTrials.gov Identifier:	NCT00668681

Purpose

This study is intended to provide data to verify safe delivery of the 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.

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

MedlinePlus related topics: Aneurysms

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures

Further study details as provided by Lombard Medical:

Estimated Enrollment:	95
Study Start Date:	April 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with and/or treated for with Abdominal Aortic Aneurysm repair

Criteria

Inclusion Criteria:

Male or female >21 years of age
Undergoing endovascualr 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00668681

Locations

United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Arizona Heart Hospital
Phoenix, Arizona, United States, 85006
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30368
United States, Missouri
Barnes Jewish Hospital
St. Louis, Missouri, United States, 63141
United States, New Hampshire
Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, United States, 03756
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10021
United States, Texas
St. Paul University Hospital
Dallas, Texas, United States, 75390
St. Lukes Episcopal Hospital
Houston, Texas, United States, 77030
United States, Wisconsin
St. Lukes Medical Center
Milwaukee, Wisconsin, United States, 53215

Sponsors and Collaborators

Lombard Medical

St. Paul University Hospital, Dallas Texas

Arizona Heart Institute

Barnes-Jewish Hospital Foundation

Mount Sinai Hospital, New York New York

St. Lukes Episcopal Hospital, Houston Texas

St. Lukes Medical Center, Wilwaukee, Wisconsin

Mary Hitchcock Memorial Hospital, Lebanon New Hampshire

University of Alabama at Birmingham

University of Florida

Emory University

Investigators

Study Chair:	Frank Arko, MD	St. Paul University Hospital, Dallas Texas
Principal Investigator:	Peter Faries, MD	Mount Sinai Hospital, New York New York
Principal Investigator:	Louis Sanchez, MD	Barnes Jewish Hospital, St. Louis Missouri
Principal Investigator:	Venkatash Ramaiah, MD	Arizona Heart Institute, Phoenix, Arizona
Principal Investigator:	Mark Mewissen, MD	St. Lukes Medical Center, Wilwaukee, Wisconsin
Principal Investigator:	Mark Fillinger, MD	Mary Hitchcock Memorial Hospital, Lebanon New Hampshire
Principal Investigator:	Zvonko Krajcer, MD	St. Lukes Episcopal Hospital, Houston Texas
Principal Investigator:	Will Jordan, MD	University of Alabama, Birmingham Alabama.
Principal Investigator:	Anthony Lee, MD	University of Florida, Gainesville, Florida
Principal Investigator:	Karthikes Kasirajan, MD	Emory University, Atlanta Georgia

More Information

Responsible Party:	St. Paul University Hospital, Dallas Texas ( Frank Arko,MD )
Study ID Numbers:	Endo060234
Study First Received:	April 25, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00668681
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lombard Medical:

Abdominal Aortic Aneurysm

Study placed in the following topic categories:

Aneurysm
Aortic Aneurysm, Abdominal
Abdominal aortic aneurysm
Vascular Diseases
Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009