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Evaluation of EndoRefix Endovascular Delivery System and Staple

Sponsor
Lombard Medical (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00668681
Collaborator
(none)
0
Enrollment
7
Locations
1
Arm
10.1
Duration (Months)
0
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: EndoRefix
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
N/A
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 :
Apr 1, 2008
Actual Primary Completion Date :
Dec 1, 2008
Anticipated Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Endorefix

Evaluation of EndoRefix Endovascular Delivery System and Staple

Device: EndoRefix

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 University of Alabama Birmingham Birmingham Alabama United States 35294
    2 Arizona Heart Hospital Phoenix Arizona United States 85006
    3 Emory University Hospital Atlanta Georgia United States 30368
    4 Mary Hitchcock Memorial Hospital Lebanon New Hampshire United States 03756
    5 Mount Sinai Hospital New York New York United States 10021
    6 St. Paul University Hospital Dallas Texas United States 75390
    7 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lombard Medical
    ClinicalTrials.gov Identifier:
    NCT00668681
    Other Study ID Numbers:
    • Endo060234
    First Posted:
    Apr 29, 2008
    Last Update Posted:
    Oct 17, 2012
    Last Verified:
    Oct 1, 2012
    Keywords provided by Lombard Medical
    Abdominal Aortic Aneurysm
    Additional relevant MeSH terms:
    Aneurysm

    Study Results

    No Results Posted as of Oct 17, 2012