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Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study (FENP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01652235
First received: July 17, 2012
Last updated: August 22, 2016
Last verified: August 2016
  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:


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 2024
Estimated Primary Completion Date: October 2019 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01652235

Contacts
Contact: Josephat Asiago, PhD 765-463-7537 Josephat.Asiago@cookmedical.com

Locations
United States, New York
Mount Sinai-West Recruiting
New York, New York, United States, 10025
Contact: James F McKinsey, MD    212-523-7460    jmckinsey@chpnet.org   
New York Presbyterian Hospital System Active, not recruiting
New York, New York, United States, 10032
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: James F. McKinsey, MD Mount Sinai-West
  More Information

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01652235     History of Changes
Other Study ID Numbers: 07-003 
Study First Received: July 17, 2012
Last Updated: August 22, 2016
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 September 23, 2016