Zenith® p-Branch® Endovascular Graft Pivotal Study

The Zenith® p-Branch® Pivotal Study is a clinical trial approved by FDA to study the safety and effectiveness of the Zenith® p-Branch® endovascular graft in combination with the Atrium iCAST™ covered stents in the treatment of abdominal aortic aneurysms.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Aortic Aneurysm Abdominal Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal 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 Alabama Birmingham Hosptial, Birmingham, Alabama, 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

Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents

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, Fenestrated graft

Primary outcomes

Treatment Success Proportion

Time frame: 12 months

Technical success and freedom from type 1 and type 3 endoleaks which require intervention, aneurysm growth, related SAE's, and related major complications

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official study title

Zenith® p-Branch® Pivotal Study

Important dates

Study start: 2015
Primary completion: 2021
Study completion: 2025
First posted: Mar 24, 2015
Registry last updated: Feb 19, 2025

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