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

Complex Abdominal Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT03159858
• Other study ID #: 16-01824
• Status: No longer available
• Phase: N/A
• First received: May 17, 2017
• Last updated: May 17, 2017

Study information

• Verified date: May 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Male
• Age group: 70 Years to 70 Years

Eligibility

Inclusion Criteria:

Exclusion Criteria:

Related Conditions & MeSH terms

• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Complex Abdominal Aortic Aneurysm

Intervention

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).

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States,