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Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

This study has been completed.
Information provided by (Responsible Party):
Cook Identifier:
First received: January 30, 2009
Last updated: December 13, 2016
Last verified: December 2016
The Zenith® Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® Low Profile AAA Endovascular Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

Condition Intervention
Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-iliac Aneurysms Device: Zenith(R) Low Profile AAA Endovascular Graft

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Patients With Major Adverse Events (MAE) [ Time Frame: 30-day ]
    MAE is defined as any occurrence of all-cause death, Q-wave myocardial infarction (MI), renal failure requiring dialysis, paralysis, stroke, bowel ischemia, or re-intubation.

  • Patients With Device Failures [ Time Frame: 12-month ]

    Device success at 12-month is defined as:

    Technical Success (successful access of the aneurysm site, deployment of the graft in the intended location, and patency of the graft at the time of deployment completion intra-operatively), and freedom from the following at 12 months: Type I or type III endoleaks requiring re-intervention, Aneurysm rupture or conversion to open surgical repair, and Aneurysm enlargement greater than 0.5 cm.

Enrollment: 120
Study Start Date: May 2008
Study Completion Date: June 2016
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment with Endovascular Graft
Device: Zenith(R) Low Profile AAA Endovascular Graft
The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
  • Vessels suitable for endovascular access and aneurysm repair

Exclusion Criteria:

  • Less than 18 years of age
  • Inability or refusal to give informed consent
  • Disease considerations that would compromise patient safety or study outcomes
  • Unsuitable arterial anatomy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00833924

  Show 27 Study Locations
Sponsors and Collaborators
Principal Investigator: Ronald Fairman, MD University of Pennsylvania
  More Information

Responsible Party: Cook Identifier: NCT00833924     History of Changes
Other Study ID Numbers: 08-013
Study First Received: January 30, 2009
Results First Received: December 18, 2015
Last Updated: December 13, 2016

Keywords provided by Cook:
Low Profile
Abdominal Aortic Aneurysms

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases processed this record on June 23, 2017