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Evaluation of EndoRefix Endovascular Delivery System and Staple (EndoRefix)

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ClinicalTrials.gov Identifier: NCT00668681
Recruitment Status : Withdrawn (Company business decision, IDE closed, no commercialization planned)
First Posted : April 29, 2008
Last Update Posted : October 17, 2012
Sponsor:
Information provided by (Responsible Party):
Lombard Medical

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.

Condition or disease Intervention/treatment Phase
AAA Graft Implant for Primary Aneurysm Treatment AAA Graft Repair to Extend Life of Implant Device: EndoRefix Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures
Study Start Date : April 2008
Actual Primary Completion Date : December 2008
Estimated Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Endorefix
Evaluation of EndoRefix Endovascular Delivery System and Staple
Device: EndoRefix




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30368
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
Sponsors and Collaborators
Lombard Medical
Investigators
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. Luke's Medical Center
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

Responsible Party: Lombard Medical
ClinicalTrials.gov Identifier: NCT00668681     History of Changes
Other Study ID Numbers: Endo060234
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012

Keywords provided by Lombard Medical:
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases