CClinicalTrials.gg
TerminatedNCT01424267Updated Oct 11, 2012

Zenith® LP Abdominal Aortic Aneurysm (AAA) Post-Market Registry

An observational study in Abdominal Aortic Aneurysm and Aorto-iliac Aneurysm, sponsored by Cook Group Incorporated. Terminated at 15 sites in 7 countries. Per ClinicalTrials.gov, last updated 2012-10-11.

Sponsored by Cook Group Incorporated · Observational

Why this study was terminated
The registry was discontinued due to significant resources required.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
76
Sex
All
01

Study summary

A registry to collect additional prospective intra-operative and follow-up information on physician use of the CE-marked Zenith® Low Profile Abdominal Aortic Aneurysm (AAA) Endovascular Graft under routine clinical care.

02

Conditions studied

  • Abdominal Aortic Aneurysm
  • Aorto-iliac Aneurysm

Keywords

  • low profile
  • endovascular graft
  • endovascular procedure
  • aortic aneurysm, abdominal aortic aneurysm
03

In context

Aneurysm

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

This study's enrollment of 76 is below the median of 151 across 443 observational studies indexed under Aneurysm.

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.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients implanted with a CE-Marked Zenith® Low Profile AAA Endovascular Graft

Inclusion criteria

  • Patient is implanted with Zenith® Low Profile AAA Endovascular Graft

Exclusion criteria

Exclusion Criteria:

  • Patients for whom this device would not normally be considered standard of care.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
76 participants (actual)

Groups and cohorts

  • 1

    Device: Zenith® Low Profile AAA Endovascular Graft

Interventions

  • DeviceZenith® Low Profile AAA Endovascular Graft

    Treatment of an abdominal aortic or aorto-iliac aneurysm with the CE-marked Zenith(R) Low Profile AAA Endovascular Graft.

06

What researchers measure

Primary outcomes

  1. graft patency and aneurysm exclusion

    Time frame: during (day 1) and after implantation through 12 months

07

Study locations

15 sites
  • AKH (General Hospital Vienna)
    Vienna, Austria
  • UHZ Hamburg GmbH (Eppendorf University Hospital)
    Hamburg, Germany
  • Klinikum rechts der Isar (RDI Munich)
    Munich, Germany
  • Klinikum Nürnberg Süd
    Nürnberg, Germany
  • Royal Victoria Hospital
    Belfast, Ireland
  • Nuovo Ospendale Civile Sant' Agostino Estense di Baggiovara
    Modena, Italy
  • Azoemda ospedaliera San Camillo Forlanini
    Rome, Italy
  • Catharina Ziekenhuis
    Eindhoven, Netherlands
  • Maastricht University Medical Center
    Maastricht, Netherlands
  • St. Olav University Hospital
    Trondheim, Norway
  • Guy's and St. Thomas' Hospital
    London, United Kingdom
  • St. Mary's Hospital
    London, United Kingdom
  • Manchester Royal Informary
    Manchester, United Kingdom
  • Freeman Hospital
    Newcastle Upon Tyne, United Kingdom
  • Royal Gwent Hospital
    Wales, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 11, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01424267
Lead sponsor
Cook Group Incorporated
Responsible party
Sponsor
First posted
Aug 26, 2011
Start date
Jul 2010
Primary completion
Aug 2012
Completion
Aug 2012
Last update
Oct 11, 2012
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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