Zenith® p-Branch® OTS Multicenter Study
NCT01740700 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2020-12-21
Summary
The purpose of the Zenith® p-Branch® OTS Multicenter Study is to provide an early clinical experience and evaluate the safety and effectiveness of the Zenith® p-Branch® in the treatment of pararenal or juxtarenal abdominal aortic aneurysms (AAA).
Conditions
- Aortic Aneurysm, Abdominal
Interventions
- DEVICE
-
p-Branch®
Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
Sponsors & Collaborators
-
Cook Research Incorporated
lead INDUSTRY
Principal Investigators
-
Mark A Farber, MD · University of North Carolina
Study Design
- Allocation
- NA
- Purpose
- DEVICE_FEASIBILITY
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2015-06-30
- Completion
- 2020-06-22
- FDA Device
- Yes
Countries
- United States
Study Locations
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