Zenith® p-Branch® OTS Multicenter Study

Overview

About this study

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).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status
Rochester, Minn. Mayo Clinic principal investigator Randall DeMartino, M.D., M.S.	Closed for enrollment

Mayo Clinic Location

Status

Rochester, Minn.

Mayo Clinic principal investigator

Randall DeMartino, M.D., M.S.

Closed for enrollment

More information

Publications

Publications are currently not available

Clinical Trials