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Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
This study has been completed.
Sponsor:
Cook Group Incorporated
Information provided by (Responsible Party):
Cook Group Incorporated
ClinicalTrials.gov Identifier:
NCT00833924
First received: January 30, 2009
Last updated: December 13, 2016
Last verified: December 2016
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Purpose
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 | Intervention |
|---|---|
| Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-iliac Aneurysms | Device: Zenith(R) Low Profile AAA Endovascular Graft |
Access to an investigational treatment associated with this study is available outside the clinical trial. More info ...
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Cook Group Incorporated:
Primary Outcome Measures:
- 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.
| Enrollment: | 120 |
| Study Start Date: | May 2008 |
| Study Completion Date: | June 2016 |
| Primary Completion Date: | October 2011 (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 (Adult, Senior) |
| 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833924
Show 27 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833924
Show 27 Study Locations
Sponsors and Collaborators
Cook Group Incorporated
Investigators
| Principal Investigator: | Ronald Fairman, MD | University of Pennsylvania |
More Information
| Responsible Party: | Cook Group Incorporated |
| ClinicalTrials.gov Identifier: | NCT00833924 History of Changes |
| Other Study ID Numbers: |
08-013 370016 |
| Study First Received: | January 30, 2009 |
| Results First Received: | December 18, 2015 |
| Last Updated: | December 13, 2016 |
Keywords provided by Cook Group Incorporated:
|
Low Profile Abdominal Aortic Aneurysms Endovascular |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Iliac Aneurysm |
Vascular Diseases Cardiovascular Diseases Aortic Diseases |
ClinicalTrials.gov processed this record on September 18, 2017