Zenith(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Cook

ClinicalTrials.gov Identifier:

NCT00875563

First received: February 19, 2009

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

February 19, 2009

Last Updated Date

March 18, 2013

Start Date ^ICMJE

January 2005

Estimated Primary Completion Date

April 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Treatment Success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Technical success (successful access, deployment, and patency of the Fenestrated Graft, and patency of vessels targeted by a fenestration intra-operatively), no type I or type III endoleaks, no AAA-related serious adverse events or major complications, and no aneurysm enlargement greater than 0.5 cm.

Original Primary Outcome Measures ^ICMJE

Treatment Success [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT00875563 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(R) Fenestrated Abdominal Aortic Aneurysm (AAA) Endovascular Graft Clinical Study

Official Title ^ICMJE

Evaluation of the Safety and Effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft

Brief Summary

The Zenith(R) Fenestrated AAA Endovascular Graft Clinical Study is a clinical investigation approved by the US FDA to study the safety and effectiveness of the Zenith(R) Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic and aorto-iliac aneurysms.

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 Aneurysms
Aorto-iliac Aneurysms
Juxtarenal Aneurysms

Intervention ^ICMJE

Device: Zenith(R) Fenestrated AAA Endovascular Graft

The Zenith(R) Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair

Study Arm (s)

Experimental: 1

Endovascular Repair

Intervention: Device: Zenith(R) Fenestrated AAA Endovascular Graft

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

Active, not recruiting

Enrollment ^ICMJE

Estimated Completion Date

April 2017

Estimated Primary Completion Date

April 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Abdominal aortic and aortoiliac aneurysms with diameter greater than or equal to 5 cm

Exclusion Criteria:

Proximal neck less than 4 mm or greater than or equal to 15 mm in length unless otherwise compromised to preclude seal
Renal artery stenosis greater than 50 percent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00875563

Other Study ID Numbers ^ICMJE

04-541, 370015, FNCT

Has Data Monitoring Committee

Not Provided

Responsible Party

Cook

Study Sponsor ^ICMJE

Cook

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Roy Greenberg, MD

The Cleveland Clinic

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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