CompletedNot Applicable

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

United States28 participantsStarted 2008-07

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Technical Success:

Timeframe: Immediately post graft deployment

Procedural Success

Timeframe: Within 30 days post graft deployment

Treatment Success

Timeframe: 12 months

Trial details

NCT IDNCT01652235

SponsorCook Research Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-26

Results submitted2024-08-20

View on ClinicalTrials.gov More Aortic Aneurysm, Abdominal trials