Zenith® p-Branch™: Single-Center Study

The Zenith® p-Branch™: Single-Center Study is a clinical trial approved by Swedish Regulatory Authority to study the safety and effectiveness of the Zenith® p-Branch™ in the treatment of abdominal aortic aneurysms.

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Key information

Conditions

Aortic Aneurysm Abdominal Aortic Aneurysm 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

Skane University Hospital

Malmö, SE-205 02, Sweden

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
Pararenal or juxtarenal AAA with history of growth >0.5 cm/year

Exclusion criteria

Age < 18 years
Life expectancy < 2 years
Pregnant or breast feeding
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
Additional medical restrictions as specified in the Clinical Investigation Plan
Additional anatomical restrictions as specified in the Clinical Investigation Plan

Treatment and study plan

Endovascular treatment (Zenith® p-Branch™ endovascular graft)

Device

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.

Primary outcomes

Technical Success

Time frame: Up to 5 years

Technical success is described as: 1) successful access of the aneurysm site, 2) successful deployment of the Zenith® p-Branch™ endovascular graft in the intended location, 3) Zenith® p-Branch-™ endovascular graft is patent at deployment completion as evidenced by intraoperative angiography, and 4) all vessels targeted with a fenestration are patent at deployment completion as evidenced by intraoperative angiography.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Acronym: PBCT

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2020
First posted: Aug 13, 2012
Registry last updated: Jul 31, 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