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

NCT03159858 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2017-05-19

No results posted yet for this study

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.

Conditions

  • Complex Abdominal Aortic Aneurysm

Interventions

DEVICE

Fenerated AAA Endovascular Graft with H&L-B One Shot Introduction System

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).

Sponsors & Collaborators

Principal Investigators

  • Neal Cayne, MD · NYU Langone Health

Eligibility

Min Age
70 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03159858 on ClinicalTrials.gov