Evaluation of EndoRefix Endovascular Delivery System and Staple

NCT00668681 | Withdrawn

• 1 other identifier: Endo060234
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

Abdominal Aortic Aneurysm

Study Arms (1)

Endorefix

ACTIVE COMPARATOR

Evaluation of EndoRefix Endovascular Delivery System and Staple

Device: EndoRefix

Interventions

EndoRefix DEVICE

Endorefix

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \>21 years of age
• Undergoing endovascular stent grafting for AAA repair
• Post endovascular stent grafting where stent stabilization is necessary due to stent fixation failure and/or persistent endoleak.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Lombard Medical: lead

Study Sites (7)

University of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Heart Hospital

Phoenix, Arizona, 85006, United States

Location

Emory University Hospital

Atlanta, Georgia, 30368, United States

Location

Mary Hitchcock Memorial Hospital

Lebanon, New Hampshire, 03756, United States

Location

Mount Sinai Hospital

New York, New York, 10021, United States

Location

St. Paul University Hospital

Dallas, Texas, 75390, United States

Location

St. Lukes Episcopal Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Frank Arko, MD

  St. Paul University Hospital, Dallas Texas

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2008
• First Posted: April 29, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: October 17, 2012

Record last verified: 2012-10

Locations

US (7)