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

This study is currently recruiting participants.
Verified February 2014 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01652235
First received: July 17, 2012
Last updated: February 3, 2014
Last verified: February 2014

July 17, 2012
February 3, 2014
July 2008
October 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01652235 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Zenith® p-Branch™ and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study
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

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.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm, Abdominal
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
Experimental: Endovascular
Zenith® p-Branch™ or Zenith® Fenestrated AAA Endovascular Graft
Intervention: Device: Zenith® p-Branch™ or Zenith® Fenestrated AAA Endovascular Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
April 2017
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Zach Dawson 765-463-7537 zdawson@medinst.com
United States
 
NCT01652235
07-003
Not Provided
Cook
Cook
Not Provided
Principal Investigator: James F. McKinsey, MD Columbia University, New York Presbyterian Hospital System
Cook
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP