Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

NCT ID: NCT01326884

Last Updated: 2013-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-11-30

Brief Summary

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

Detailed Description

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Conditions

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Abdominal Aortic Aneurysm Aorto-iliac Aneurysm Iliac Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Endovascular Repair

Group Type OTHER

ZLP

Intervention Type DEVICE

ZLP Graft

Interventions

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ZLP

ZLP Graft

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald M. Fairman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Nara Medical University

Nara, , Japan

Site Status

Jikei University Hospital

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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10-004

Identifier Type: -

Identifier Source: org_study_id

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