Zenith® p-Branch® OTS Multicenter Study

Completed · Not applicable

Conditions studied: Aortic Aneurysm, Abdominal

In brief

The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).

Key facts

Study ID

NCT01740700

Run by

Cook Research Incorporated

People needed

30

Starts

2013-01-01

Expected to finish

2020-06-22

Last updated by the study team

2020-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter
• Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year
• Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation

You may not qualify if…

• Age <18 years
• Life expectancy <2 years
• Pregnant, breast-feeding, or planning on becoming pregnant within 60 months
• Inability or refusal to give informed consent by the patient or a legally authorized representative
• Unwilling or unable to comply with the follow-up schedule
• Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.)
• Additional medical restrictions as specified in the Clinical Investigation Plan
• Additional anatomical restrictions as specified in the Clinical Investigation Plan

Where it is running

• University of Florida — Gainesville, Florida, United States
• Methodist Hospital of Indiana — Indianapolis, Indiana, United States
• Community Heart and Vascular Hospital — Indianapolis, Indiana, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Barnes-Jewish Hospital — St Louis, Missouri, United States
• Mercy Hospital — St Louis, Missouri, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States
• The Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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