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Evaluation of EndoRefix Endovascular Delivery System and Staple

NCT00668681 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2012-10-17

No results posted yet for this study

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

Interventions

DEVICE

EndoRefix

Sponsors & Collaborators

  • Lombard Medical

    lead INDUSTRY

Principal Investigators

  • Frank Arko, MD · St. Paul University Hospital, Dallas Texas

  • Peter Faries, MD · Mount Sinai Hospital, New York

  • Louis Sanchez, MD · Barnes Jewish Hospital, St. Louis Missouri

  • Venkatash Ramaiah, MD · Arizona Heart Institute, Phoenix, Arizona

  • Mark Mewissen, MD · St. Luke's Medical Center

  • Mark Fillinger, MD · Mary Hitchcock Memorial Hospital, Lebanon New Hampshire

  • Zvonko Krajcer, MD · St. Lukes Episcopal Hospital, Houston Texas

  • Will Jordan, MD · University of Alabama, Birmingham Alabama.

  • Anthony Lee, MD · University of Florida, Gainesville, Florida

  • Karthikes Kasirajan, MD · Emory University, Atlanta Georgia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-12-31
Completion
2009-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00668681 on ClinicalTrials.gov