Endovascular Exclusion of AAA Utilizing Fenestrated Stent Grafts - Full Text View

Endovascular Exclusion of AAA Utilizing Fenestrated Stent Grafts

This study is currently recruiting participants.
Verified by The Cleveland Clinic, December 2007

Sponsors and Collaborators:	The Cleveland Clinic Roy Greenberg, MD
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00583050

Purpose

The purpose of the study is to evaluate the role of fenestrated stent-grafts in the exclusion of abdominal aortic and thoracoabdominal aneurysms. The evaluation shall be conducted with subjects that would be expected to have great difficulty tolerating open surgical repair and anatomies not suitable for devices currently marketed.

Condition	Intervention	Phase
Thoracoabdominal Aneurysm Abdominal Aortic Aneurysm	Procedure: Endovascular Stentgraft	Phase I

MedlinePlus related topics:

Aneurysms

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety Study

Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:

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

Estimated Enrollment:	450
Study Start Date:	February 2001
Estimated Study Completion Date:	December 2020
Estimated Primary Completion Date:	December 2020 (Final data collection date for primary outcome measure)

Intervention Details:

Research Endovascular Stentgraft

Eligibility

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

Criteria

Inclusion Criteria:

At least 18 years of age.
Not pregnant
Willing and able to comply with two-year follow-up period.
Willing and able to give informed consent prior to enrollment
No known allergy to stainless steel or polyester
No history of anaphylactic reaction to contrast material with an inability to properly prophylax the patient appropriately.
Life expectancy greater than two years
High risk candidate for open surgical repair

Exclusion Criteria:

see above

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583050

Contacts


Contact: Leslie Geiger, RN	216-445-7560	geigerl@ccf.org

Locations


United States, Ohio
	Cleveland Clinic	Recruiting
	Cleveland, Ohio, United States, 44195
	Sub-Investigator: Daniel Clair, MD
	Sub-Investigator: Sean Lyden, MD
	Sub-Investigator: Eric Roselli, MD
	Sub-Investigator: Matthew Eagleton, MD
	Sub-Investigator: Sunita Srivastava, MD

Sponsors and Collaborators

The Cleveland Clinic

Roy Greenberg, MD

Investigators


Principal Investigator:	Roy L Greenberg, MD	Cleveland Clinic

More Information

Responsible Party:	Cleveland Clinic ( Roy Greenberg, MD )
Study ID Numbers:	G010002, IRB 4281
First Received:	December 20, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00583050
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Aortic Diseases

Aneurysm

Aortic Aneurysm, Abdominal

Abdominal aortic aneurysm

Vascular Diseases

Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 31, 2008