Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00833924
First received: January 30, 2009
Last updated: May 15, 2014
Last verified: May 2014

January 30, 2009
May 15, 2014
May 2009
June 2020   (final data collection date for primary outcome measure)
Composite rate of adverse clinical/device events [ Time Frame: during and after implantation ] [ Designated as safety issue: Yes ]
Adverse events and device success. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00833924 on ClinicalTrials.gov Archive Site
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Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft

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 used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg Graft to treat abdominal aortic, aorto-iliac, and iliac aneurysms.

Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Abdominal Aortic Aneurysms
  • Iliac Aneurysms
  • Aorto-iliac Aneurysms
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.
1
Treatment with Endovascular Graft
Intervention: Device: Zenith(R) Low Profile AAA Endovascular Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
272
June 2020
June 2020   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   China,   Germany,   Russian Federation,   Sweden
 
NCT00833924
08-013, 370016
Not Provided
Cook
Cook
Not Provided
Principal Investigator: Ronald Fairman, MD University of Pennsylvania
Cook
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP