Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

This study is currently recruiting participants.

Verified November 2011 by The Cleveland Clinic

First Received on December 20, 2007. Last Updated on November 14, 2011 History of Changes

Sponsor:	The Cleveland Clinic
Collaborator:	Greenberg, Roy, M.D.
Information provided by (Responsible Party):	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00583414

Purpose

The purpose of this study is to assess the role of abdominal aneurysm and iliac aneurysm exclusion using an endovascular prosthesis.

Condition	Intervention	Phase
Abdominal Aortic Aneurysm Iliac Aneurysm Hypogastric Aneurysm	Procedure: Endovascular Repair of Aortic Aneurysm	Phase I

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

Estimated Enrollment:	400
Study Start Date:	September 1998
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	December 2020 (Final data collection date for primary outcome measure)

Intervention Details:

Endovascular Repair of Aortic Aneurysm

Other Name: Cook Zenith

Eligibility

Criteria

Inclusion Criteria:

The aneurysm is >/= 5 cm or larger, or with a high risk of rupture due to its shape, history of growth, symptoms, or the presence of a large (>2 cm) iliac aneurysm
Anticipated mortality greater than 10 percent with conventional surgery
Life expectancy greater than 2 years
Suitable arterial anatomy
Absence of systemic disease or allergy that precludes an endovascular repair
Capable of giving informed consent and willingness to comply with the follow-up schedule

Exclusion Criteria:

Pregnancy
History of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately
Allergy to stainless steel or polyester
Unwilling to comply with the follow-up schedule
Serious or systemic groin infection
Coagulopathy, other than coumadin therapy
Inability to give informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583414

Contacts

Contact: Nancy P Simpson

216-444-9729

Locations

United States, Ohio
Cleveland Clinic	Recruiting
Cleveland, Ohio, United States, 44195
Sub-Investigator: Dan Clair, MD
Sub-Investigator: Sean Lyden, MD
Sub-Investigator: Sunita Srivastava, MD
Sub-Investigator: Matthew Eagleton, MD
Sub-Investigator: Tara Mastracci, MD

Sponsors and Collaborators

The Cleveland Clinic

Greenberg, Roy, M.D.

Investigators

Principal Investigator:

Roy K Greenberg, MD

The Cleveland Clinic

More Information

No publications provided

Responsible Party:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00583414 History of Changes
Other Study ID Numbers:	G980198, IRB 3264
Study First Received:	December 20, 2007
Last Updated:	November 14, 2011
Health Authority:	United States: Food and Drug Administration

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 12, 2012