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Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

This study is currently recruiting participants.
Verified March 2013 by Cook
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00833924
First received: January 30, 2009
Last updated: March 16, 2013
Last verified: March 2013
History of Changes
  Purpose

The Zenith(R) Low Profile AAA Endovascular Graft Clinical Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft in the treatment of 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

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:

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:
  • Composite rate of adverse clinical/device events [ Time Frame: during and after implantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 177
Study Start Date: May 2009
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833924

Contacts
Contact: Alison Conovaloff, MS 765-463-7537 aconovaloff@medinst.com

  Show 28 Study Locations
Sponsors and Collaborators
Cook
Investigators
Principal Investigator: Ronald Fairman, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT00833924     History of Changes
Other Study ID Numbers: 08-013, 370016
Study First Received: January 30, 2009
Last Updated: March 16, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Sweden: Medical Products Agency
Canada: Health Canada

Keywords provided by Cook:
Low Profile
Abdominal Aortic Aneurysms
Endovascular

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Iliac Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 23, 2013