We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01652235
Recruitment Status : Recruiting
First Posted : July 30, 2012
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Aortic Aneurysm, Abdominal Device: Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2008
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. evaluate perfusion of visceral vessels [ Time Frame: up to 5 years ]
    evaluate perfusion of visceral vessels (renal, mesenteric, and systemic)


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Group Incorporated
Investigators
Principal Investigator: James F. McKinsey, MD Mount Sinai-West
More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT01652235     History of Changes
Other Study ID Numbers: 07-003
First Posted: July 30, 2012    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: January 2018

Keywords provided by Cook Group Incorporated:
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