Zenith® p-Branch® OTS Multicenter Study

Cook Research Incorporated30 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Aortic Aneurysm, Abdominal

Interventions

p-Branch®DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

University of Florida

Gainesville, Florida, United States

Methodist Hospital of Indiana

Indianapolis, Indiana, United States

Community Heart and Vascular Hospital

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Technical success

Technical success is defined as successful access and deployment of the graft and patency of the vessels targeted by fenestrations.

Time frame: Within 30 days

Data from ClinicalTrials.gov

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