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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

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

Official Title

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

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.

Detailed Description

      The Custom Made Branched/Fenestrated Endovascular Device to be used in this treatment plan is
      not Food and Drug Administration (FDA)-approved, and is approved for use only in a clinical
      study. However, the FDA has allowed the use of this device for compassionate use.

      The devices used are tubular grafts made of polyester fabric sewn to metal stents. The upper
      part of the grafts includes fenestrations (holes) that allow the grafts to be located above
      or near major arteries that branch off of the aorta (celiac artery, superior mesenteric
      artery (SMA), and renal arteries) without blocking blood flow to them. The celiac artery
      supplies blood to internal organs including the liver and stomach. The SMA supplies blood to
      internal organs as well, including parts of the large and small intestines. The renal
      arteries supply blood to the kidneys. Grafts with branches and/or fenestrations are needed
      when the aneurysm is located near these major arteries. The major arteries that branch off of
      the aorta (celiac artery, SMA, and renal arteries) may also be treated using stents (small
      tubular metal structures) to help keep the arteries open and aligned with the graft
      fenestrations (holes).

Study Type

Expanded Access

Condition

Complex Abdominal Aortic Aneurysm

Intervention

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Eligibility Criteria

        Inclusion Criteria:

        -

        Exclusion Criteria:

        -

Gender

Male

Ages

70 Years - 70 Years

Contacts

Neal Cayne, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT03159858

Organization ID

16-01824

Responsible Party

Sponsor

Study Sponsor

NYU Langone Health

Study Sponsor

Neal Cayne, MD, Principal Investigator, NYU Langone Health

Verification Date

May 2017