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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Lombard Medical
ClinicalTrials.gov Identifier:
NCT00668681
First received: April 25, 2008
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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 Intervention
AAA Graft Implant for Primary Aneurysm Treatment
AAA Graft Repair to Extend Life of Implant
Device: EndoRefix

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Data Collection for Delivery System and Use of Staple in Endovascular Procedures

Resource links provided by NLM:


Further study details as provided by Lombard Medical:

Enrollment: 0
Study Start Date: April 2008
Estimated Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Endorefix
Evaluation of EndoRefix Endovascular Delivery System and Staple
Device: EndoRefix
Other Name: EndoRefix

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, 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. 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

No publications provided

Responsible Party: Lombard Medical
ClinicalTrials.gov Identifier: NCT00668681     History of Changes
Other Study ID Numbers: Endo060234
Study First Received: April 25, 2008
Last Updated: October 15, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Lombard Medical:
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 15, 2014