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Approved for marketingNCT02577562Updated Nov 24, 2017

Zenith® Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Continued Access Study

An expanded access record providing Zenith® Fenestrated AAA Endovascular Graft in Abdominal Aortic Aneurysms, Aorto-iliac Aneurysms and Juxtarenal Aneurysms, sponsored by Cook Group Incorporated. Approved for marketing at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-11-24.

Sponsored by Cook Group Incorporated · Expanded access

Study type
Expanded access
Ages
18 Years and older
Sex
All
01

Study summary

The Zenith®Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

02

Conditions studied

  • Abdominal Aortic Aneurysms
  • Aorto-iliac Aneurysms
  • Juxtarenal Aneurysms
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In context

Aneurysm

960 studies on the registry are indexed under Aneurysm; 175 are open to participants now.

Browse Aneurysm studies →

Lead sponsor

Cook Group Incorporated is the lead sponsor of 73 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm

Exclusion criteria

Exclusion Criteria:

  • Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
  • Renal artery stenosis greater than 50 percent
05

Access details

Study type
Expanded access

Available treatment

  • DeviceZenith® Fenestrated AAA Endovascular Graft

    The Zenith® Fenestrated AAA Endovascular Graft with the H\&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair

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Where to request access

15 sites
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • Shands Hospital
    Gainesville, Florida 32610, United States
  • University of Florida
    Gainesville, Florida 32610, United States
  • The Indiana Heart Hospital
    Indianapolis, Indiana 46250, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • University of Massachusetts Medical School
    Worcester, Massachusetts 01655, United States
  • Mayo Clinic Rochester
    Rochester, Minnesota 55905, United States
  • Barnes-Jewish Hospital
    Saint Louis, Missouri 63110, United States
  • Dartmouth Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • NYU Medical Center
    New York, New York 10016, United States
  • University of North Carolina Hospital
    Chapel Hill, North Carolina 27599, United States
  • Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Hospital of the University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • University of Pittsburgh Medical Center
    Pittsburgh, Pennsylvania 15213, United States
  • Harborview Medical Center
    Seattle, Washington 98104, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT02577562
Lead sponsor
Cook Group Incorporated
Responsible party
Sponsor
First posted
Oct 16, 2015
Last update
Nov 24, 2017
View the source record on ClinicalTrials.gov ↗

Requesting access

Expanded access is arranged between your doctor and the company. Ask your care team to contact the provider listed on this record.

No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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