Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Cook

ClinicalTrials.gov Identifier:

NCT01326884

First received: March 21, 2011

Last updated: March 11, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 21, 2011

Last Updated Date

March 11, 2013

Start Date ^ICMJE

February 2011

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Composite rate of adverse clinical/device events [ Time Frame: During (day 1) and after implantation through 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01326884 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Zenith Low Profile AAA Endovascular Graft (ZLP) Clinical Study

Official Title ^ICMJE

ZLP Clinical Study

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Abdominal Aortic Aneurysm
Aorto-iliac Aneurysm
Iliac Aneurysm

Intervention ^ICMJE

Device: ZLP

ZLP Graft

Study Arm (s)

Endovascular Repair

Intervention: Device: ZLP

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

20 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Japan

Administrative Information

NCT Number ^ICMJE

NCT01326884

Other Study ID Numbers ^ICMJE

10-004

Has Data Monitoring Committee

Not Provided

Responsible Party

Cook

Study Sponsor ^ICMJE

Cook

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ronald M. Fairman, MD

University of Pennsylvania

Information Provided By

Cook

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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