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Zenith® p-Branch™ and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study (FENP)

This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01652235
First received: July 17, 2012
Last updated: March 18, 2013
Last verified: March 2013
History of Changes
  Purpose

The Zenith® p-Branch™ and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch™ and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.


Condition Intervention
Aortic Aneurysm, Abdominal
 Device: Zenith® p-Branch™ or Zenith® Fenestrated AAA Endovascular Graft

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment With the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch™ and the Effects on Organ and Extremity Perfusion

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • evaluate perfusion of visceral vessels [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
    evaluate perfusion of visceral vessels (renal, mesenteric, and systemic)


Estimated Enrollment: 40
Study Start Date: July 2008
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endovascular
Zenith® p-Branch™ or Zenith® Fenestrated AAA Endovascular Graft
 Device: Zenith® p-Branch™ or Zenith® Fenestrated AAA Endovascular Graft
Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Other Names:
  • Endovascular stent
  • Stent-graft

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter
  • Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months
  • Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter

Exclusion Criteria:

  • Age < 18 years
  • Life expectancy < 2 years
  • Pregnant or breast feeding
  • Inability or refusal to give informed consent
  • Unwilling or unable to comply with the follow-up schedule
  • Additional medical restrictions as specified in the Clinical Investigation Plan
  • Additional anatomical restrictions as specified in the Clinical Investigation Plan
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01652235

Contacts
Contact: Zach Dawson 765-463-7537 zdawson@medinst.com

Locations
United States, New York
New York Presbyterian Hospital System Recruiting
New York, New York, United States, 10032
Contact: James F. McKinsey, MD     212-342-3255     jfm2111@columbia.edu    
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: James F. McKinsey, MD Columbia University, New York Presbyterian Hospital System
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01652235     History of Changes
Other Study ID Numbers: 07-003
Study First Received: July 17, 2012
Last Updated: March 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Cook:
Abdominal aortic aneurysm
Endovascular
Fenestration
 Juxtarenal
Off-the-shelf
Pararenal

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 16, 2013