Zenith(R) Low Profile AAA Endovascular Graft Clinical Study

This study is currently recruiting participants.

Verified September 2011 by Cook

First Received on January 30, 2009. Last Updated on September 23, 2011 History of Changes

Sponsor:	Cook
Information provided by (Responsible Party):	Cook
ClinicalTrials.gov Identifier:	NCT00833924

Purpose

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

Condition	Intervention
Abdominal Aortic Aneurysms Iliac Aneurysms Aorto-iliac Aneurysms	Device: Zenith(R) Low Profile AAA Endovascular Graft

Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Evaluation of the Safety and Effectiveness of the Zenith(R) Low Profile AAA Endovascular Graft

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Further study details as provided by Cook:

Primary Outcome Measures:

Composite rate of adverse clinical/device events [ Time Frame: during and after implantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	177
Study Start Date:	May 2009
Estimated Study Completion Date:	January 2017
Estimated Primary Completion Date:	January 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Treatment with Endovascular Graft	Device: Zenith(R) Low Profile AAA Endovascular Graft The Zenith(R) Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Abdominal aortic, aortoiliac, and iliac aneurysms of appropriate size
Vessels suitable for endovascular access and aneurysm repair

Exclusion Criteria:

Less than 18 years of age
Inability or refusal to give informed consent
Disease considerations that would compromise patient safety or study outcomes
Unsuitable arterial anatomy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833924

Contacts

Contact: Alison Conovaloff, MS

765-463-7537

aconovaloff@medinst.com

Show 28 Study Locations

Sponsors and Collaborators

Cook

Investigators

Principal Investigator:

Ronald Fairman, MD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Cook
ClinicalTrials.gov Identifier:	NCT00833924 History of Changes
Other Study ID Numbers:	08-013, 370016
Study First Received:	January 30, 2009
Last Updated:	September 23, 2011
Health Authority:	United States: Food and Drug Administration; Germany: Federal Institute for Drugs and Medical Devices; Sweden: Medical Products Agency; Canada: Health Canada

Keywords provided by Cook:

Low Profile
Abdominal Aortic Aneurysms
Endovascular

Additional relevant MeSH terms:

Aneurysm
Aortic Aneurysm
Iliac Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on February 09, 2012