Compassionate Use Treatment for a Single Patient With a Custom Made Branched/Fenestrated Endovascular Device for the Treatment of Complex Abdominal Aortic Aneurysm
1 other identifier
expanded_access
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
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1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2017
CompletedFirst Posted
Study publicly available on registry
May 19, 2017
CompletedMay 19, 2017
May 1, 2017
May 17, 2017
May 17, 2017
Conditions
Keywords
Interventions
The Compassionate Use Request is for the use of the Cook Zenith Fenestrated Endovascular Graft (4 branches) for the treatment of a 70-year-old male patient considered unfit for open surgical repair of his 6cm paravisceral abdominal aortic aneurism (AAA).
Eligibility Criteria
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Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Neal Cayne, MD
NYU Langone Health
Study Design
- Study Type
- expanded access
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2017
First Posted
May 19, 2017
Last Updated
May 19, 2017
Record last verified: 2017-05