Clinical Trial Details

NCT ID: NCT01652235
Date Last Changed: August 22, 2016

Overview

Research Study Summary

A clinical trial seeking patients for a research study for the treatment of Abdominal Aortic Aneurysm (AAA)

Research Study 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

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.

To Learn more

Recruitment Details

Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Cook
Duration
135 Months
Facility Type
N/A
Compensation

Eligibility

Both Male and Female ages 18 Years and up

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

Site Locations (1)

Country State City Zip Facility and Contact
United States New York New York 10025 Mount Sinai-West
James F McKinsey, MD
212-523-7460
jmckinsey@chpnet.org

Contact

Josephat Asiago, PhD
765-463-7537
E-mail:

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