This trial is active, not recruiting.

Condition aortic aneurysm, abdominal
Treatment p-branch®
Sponsor Cook
Start date January 2013
End date June 2015
Trial size 30 participants
Trial identifier NCT01740700, 12-002


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).

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose device feasibility
Masking no masking
p-branch® Endovascular graft
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.

Primary Outcomes

Technical success
time frame: Within 30 days

Eligibility Criteria

All participants at least 18 years old.

Inclusion Criteria: - Pararenal or juxtarenal AAA ≥5.0 cm in diameter or 2 times the normal aortic diameter - Pararenal or juxtarenal AAA with history of growth ≥0.5 cm/year - Saccular aneurysm with aortic diameter greater than 1.5 times the normal aortic diameter that is deemed to be at risk for rupture based upon physician interpretation Exclusion Criteria: - Age <18 years - Life expectancy <2 years - Pregnant, breast-feeding, or planning on becoming pregnant within 60 months - Inability or refusal to give informed consent by the patient or a legally authorized representative - Unwilling or unable to comply with the follow-up schedule - Simultaneously participating in another investigative device or drug study. (The patient must have completed the primary endpoint of any previous study at least 30 days prior to enrollment in this study.) - Additional medical restrictions as specified in the Clinical Investigation Plan - Additional anatomical restrictions as specified in the Clinical Investigation Plan

Additional Information

Official title Zenith® p-Branch® Multicenter Study
Principal investigator Mark A Farber, MD
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Cook.