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Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00833924
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : January 29, 2016
Last Update Posted : April 4, 2018
Sponsor:
Information provided by (Responsible Party):
Cook Group Incorporated

January 30, 2009
February 2, 2009
December 18, 2015
January 29, 2016
April 4, 2018
May 2008
October 2011   (Final data collection date for primary outcome measure)
  • 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.

Adverse events and device success. [ Time Frame: 30 days ]
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 to treat abdominal aortic, aorto-iliac, and iliac aneurysms.
Not Provided
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (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.
 
Completed
120
Same as current
June 2016
October 2011   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
China,   Germany,   Russian Federation,   Sweden,   United States
Canada,   Ireland
 
NCT00833924
08-013
370016
Not Provided
Not Provided
Not Provided
Cook Group Incorporated
Cook Group Incorporated
Not Provided
Principal Investigator: Ronald Fairman, MD University of Pennsylvania
Cook Group Incorporated
March 2018

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