Zenith® p-Branch® OTS Multicenter Study

Zenith® p-Branch® Multicenter Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01740700

Enrollment

Registered

2012-12-04

Start date

2013-01-31

Completion date

2020-06-22

Last updated

2020-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Aneurysm, Abdominal

Keywords

Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal

Brief 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).

Interventions

DEVICEp-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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Technical success	Within 30 days	Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026