Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2007

Last Updated Date

September 30, 2009

Start Date ^ICMJE

September 1998

Estimated Primary Completion Date

December 2020 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Saftey [ Time Frame: Undecided ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00583414 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Official Title ^ICMJE

Endovascular Exclusion of Abdominal Aortic Aneurysms in High Risk Patients

Brief Summary

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

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

Abdominal Aortic Aneurysm
Iliac Aneurysm
Hypogastric Aneurysm

Intervention ^ICMJE

Procedure: Endovascular Repair of Aortic Aneurysm

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

December 2020

Estimated Primary Completion Date

December 2020 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Nancy P Simpson

216-444-9729

simpson@ccf.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00583414

Responsible Party

Roy Greenberg, Cleveland Clinic

Study ID Numbers ^ICMJE

G980198, IRB 3264

Study Sponsor ^ICMJE

The Cleveland Clinic

Collaborators ^ICMJE

Roy Greenberg, MD

Investigators ^ICMJE

Principal Investigator:

Roy K Greenberg, MD

Cleveland Clinic

Information Provided By

The Cleveland Clinic

Verification Date

September 2009

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