Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

Cook Group Incorporated27 enrolled

Overview

A prospective study conducted in Japan to collect confirmatory peri-operative and 30-day information on use of the Zenith LP AAA Graft.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Abdominal Aortic Aneurysm Aorto-iliac Aneurysm Iliac Aneurysm

Interventions

ZLPDEVICE

ZLP Graft

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Abdominal aortic, aorto-iliac, and iliac aneurysms of appropriate size * Vessels suitable for endovascular access and aneurysm repair Exclusion Criteria: * Less than 20 years of age * Inability or refusal to give informed consent * Disease considerations that would compromise patient safety or study outcomes * Unsuitable arterial anatomy

Locations (2)

Nara Medical University

Nara, Japan

Jikei University Hospital

Tokyo, Japan

Outcomes

Primary Outcomes

Composite rate of adverse clinical/device events

Time frame: During (day 1) and after implantation through 12 months

Data from ClinicalTrials.gov

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