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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

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-iliac Aneurysms Device: Zenith(R) Low Profile AAA Endovascular Graft Not Applicable

Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial.   More info ...

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft
Study Start Date : May 2008
Actual Primary Completion Date : October 2011
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833924


Locations
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Sponsors and Collaborators
Cook Group Incorporated
Investigators
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Principal Investigator: Ronald Fairman, MD University of Pennsylvania
More Information
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Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00833924    
Other Study ID Numbers: 08-013
370016
First Posted: February 2, 2009    Key Record Dates
Results First Posted: January 29, 2016
Last Update Posted: April 4, 2018
Last Verified: March 2018
Keywords provided by Cook Group Incorporated:
Low Profile
Abdominal Aortic Aneurysms
Endovascular
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Iliac Aneurysm
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases