Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study

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.

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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

Mount Sinai-West, New York, United States

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Zenith® p-Branch® or Zenith® Fenestrated AAA 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.

Other names: Endovascular stent, Stent-graft

Primary outcomes

Technical Success:

Time frame: Immediately post graft deployment

Successful access of the aneurysm site and deployment of the Zenith® Fenestrated AAA Endovascular Graft or the Zenith® p-Branch™ in the intended location. The endovascular graft and all vessels targeted with fenestrations must be patent at the time of deployment completion as evidenced by intraoperative angiography
Procedural Success

Time frame: Within 30 days post graft deployment
Technical Success, with all of the following at post-procedure (within 30 days):
- No type I or type III endoleaks;
- No procedure related serious adverse events or major complications;
- Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.
Treatment Success

Time frame: 12 months
Procedural Success, with all of the following at 12 months:
- No type I or type III endoleaks;
- No serious adverse events or major complications;
- No aneurysm enlargement greater than 0.5 cm;
- Patency of the endovascular graft and all vessels targeted with fenestrations as evidenced by CT scan, angiography or by duplex ultrasound in those patients experiencing renal failure or otherwise unable to undergo contrast enhanced CT scan.

Sponsors and collaborators

Lead sponsor

Cook Research Incorporated

Industry

Registry information

Official 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

Acronym: FENP

Important dates

Study start: 2008
Primary completion: 2023
Study completion: 2023
First posted: Jul 30, 2012
Registry last updated: Sep 19, 2024

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