Evaluation of EndoRefix Endovascular Delivery System and Staple (EndoRefix)

October 15, 2012 updated by: Lombard Medical

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Arizona Heart Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30368
        • Emory University Hospital
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Mary Hitchcock Memorial Hospital
    • New York
      • New York, New York, United States, 10021
        • Mount Sinai Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • St. Paul University Hospital
      • Houston, Texas, United States, 77030
        • St. Lukes Episcopal Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lombard Medical

Investigators

  • Principal Investigator: Mark Mewissen, MD, St. Luke's Medical Center
  • 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 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2008

Study Completion (Anticipated)

February 1, 2009

Study Registration Dates

First Submitted

April 25, 2008

First Submitted That Met QC Criteria

April 28, 2008

First Posted (Estimate)

April 29, 2008

Study Record Updates

Last Update Posted (Estimate)

October 17, 2012

Last Update Submitted That Met QC Criteria

October 15, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endo060234

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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