Zenith® p-Branch® OTS Multicenter Study

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).

Completed

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Key information

Conditions

Aortic Aneurysm, Abdominal Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida, Gainesville, Florida, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

p-Branch®

Device

Instead of making a large incision in the abdomen, 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 graft, Endovascular stent, Stent-graft

Primary outcomes

Technical success

Time frame: Within 30 days

Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Zenith® p-Branch® Multicenter Study

Important dates

Study start: 2013
Primary completion: 2015
Study completion: 2020
First posted: Dec 4, 2012
Registry last updated: Dec 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed