Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

This study is currently recruiting participants.

Verified by The Cleveland Clinic, November 2008

First Received: December 20, 2007 Last Updated: November 5, 2008 History of Changes

Sponsors and Collaborators:	The Cleveland Clinic Roy Greenberg, MD
Information provided by:	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

MedlinePlus related topics: Aneurysms Aortic Aneurysm

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study
Official Title:	Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

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

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 (>3.5 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: Eric Roselli, MD
Sub-Investigator: Tara Mastracci, MD

Sponsors and Collaborators

The Cleveland Clinic

Roy Greenberg, MD

Investigators

Principal Investigator:

Roy K Greenberg, MD

Cleveland Clinic

More Information

No publications provided

Responsible Party:	Cleveland Clinic ( Roy Greenberg )
Study ID Numbers:	G980198, IRB 3264
Study First Received:	December 20, 2007
Last Updated:	November 5, 2008
ClinicalTrials.gov Identifier:	NCT00583414 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases

Iliac Aneurysm
Aortic Aneurysm
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases

Iliac Aneurysm
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on May 07, 2009