Compassionate Use Treatment for a Single Patient With a Custom Made Branched/Fenestrated Endovascular Device for the Treatment of Complex Abdominal Aortic Aneurysm

NO_LONGER_AVAILABLE

Conditions studied: Complex Abdominal Aortic Aneurysm

In brief

The FENESTRATED AAA ENDOVASCULAR GRAFT WITH THE H\&L-B ONE-SHOT™ INTRODUCTION SYSTEM is neither commercially available or available as part of a clinical trial. IRB approval of this protocol was requested so that Cook, Incorporated may apply to the FDA for approval for one-time use of this patient-specific device for compassionate use for patient AO. It is a custom made endovascular device consisting of4 fenestrations for the celiac, SMA (superior mesenteric) and left and right renal arteries.

Key facts

Study ID

NCT03159858

Run by

NYU Langone Health

Last updated by the study team

2017-05-19

Who can join

Age: 70 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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