Zenith(R) Low Profile AAA Endovascular Graft Clinical Study
This study is currently recruiting participants.
(see Contacts and Locations)
Verified February 2015 by Cook
Sponsor:
Cook
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00833924
First received: January 30, 2009
Last updated: February 12, 2015
Last verified: February 2015
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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 used in conjunction with the Zenith® Spiral-Z® AAA Iliac Leg 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 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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:
Primary Outcome Measures:
- Composite rate of adverse clinical/device events [ Time Frame: during and after implantation ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 272 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | June 2021 |
| Estimated Primary Completion Date: | June 2017 (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 |
| Genders Eligible for Study: | Both |
| 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 51 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00833924
Contacts
| Contact: Ryan Schoch | 765-463-7537 | rschoh@medinst.com |
Show 51 Study Locations
Sponsors and Collaborators
Cook
Investigators
| Principal Investigator: | Ronald Fairman, MD | University of Pennsylvania |
More Information
No publications provided
| Responsible Party: | Cook |
| ClinicalTrials.gov Identifier: | NCT00833924 History of Changes |
| Other Study ID Numbers: | 08-013, 370016 |
| Study First Received: | January 30, 2009 |
| Last Updated: | February 12, 2015 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Sweden: Medical Products Agency Canada: Health Canada |
Keywords provided by Cook:
|
Low Profile Abdominal Aortic Aneurysms Endovascular |
Additional relevant MeSH terms:
|
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Iliac Aneurysm |
Aortic Diseases Cardiovascular Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015