Evaluation of EndoRefix Endovascular Delivery System and Staple

This study has been withdrawn prior to enrollment.

(Company business decision, IDE closed, no commercialization planned)

Sponsor:

Collaborators:

St. Paul University Hospital, Dallas Texas

Arizona Heart Institute

Mount Sinai Hospital, New York

St. Lukes Episcopal Hospital, Houston Texas

Mary Hitchcock Memorial Hospital, Lebanon New Hampshire

University of Alabama at Birmingham

Emory University

Information provided by:

Lombard Medical

ClinicalTrials.gov Identifier:

NCT00668681

First received: April 25, 2008

Last updated: February 3, 2010

Last verified: February 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

April 25, 2008

Last Updated Date

February 3, 2010

Start Date ^ICMJE

April 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00668681 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Evaluation of EndoRefix Endovascular Delivery System and Staple

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Biospecimen

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

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

Intervention ^ICMJE

Study Group/Cohort (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2009

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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)

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00668681

Other Study ID Numbers ^ICMJE

Endo060234

Has Data Monitoring Committee

Responsible Party

Frank Arko,MD, St. Paul University Hospital, Dallas Texas

Study Sponsor ^ICMJE

Lombard Medical

Collaborators ^ICMJE

St. Paul University Hospital, Dallas Texas
Arizona Heart Institute
Mount Sinai Hospital, New York
St. Lukes Episcopal Hospital, Houston Texas
Mary Hitchcock Memorial Hospital, Lebanon New Hampshire
University of Alabama at Birmingham
Emory University

Investigators ^ICMJE

Study Chair:	Frank Arko, MD	St. Paul University Hospital, Dallas Texas
Principal Investigator:	Peter Faries, MD	Mount Sinai Hospital, 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

Information Provided By

Lombard Medical

Verification Date

February 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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