Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
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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
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Condition or disease | Intervention/treatment | Phase |
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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 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 |
Arm | Intervention/treatment |
---|---|
1
Treatment with Endovascular Graft
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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. |
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
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

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

Principal Investigator: | Ronald Fairman, MD | University of Pennsylvania |
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 |
Low Profile Abdominal Aortic Aneurysms Endovascular |
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Iliac Aneurysm |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |