Endovascular Treatment of Thoracic Aortic Aneurysms Using the TALENT Stent Graft System

Stanford University1 site in 1 country29 target enrollmentJanuary 2002

ConditionsAortic Aneurysm, Thoracic

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Aortic Aneurysm, Thoracic
Sponsor: Stanford University
Enrollment: 29
Locations: 1
Primary Endpoint: Aneurysm exclusion
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine whether the system is safe and effective for the intended use of treating descending thoracic aortic aneurysms.

Registry

clinicaltrials.gov

Start Date

January 2002

End Date

December 2005

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient is a candidate for repair of a descending thoracic aortic aneurysm.
•Patient has one or more of the following:
•Descending thoracic aneurysm, 5 cm in diameter or greater with proximal and distal neck suitable for stent graft placement.
•Aneurysm is 4-5 cm in diameter but has increased in size by 0.5 cm in last 6 months.
•Maximum diameter of aneurysm exceeds one and one-half times the transverse dimension of an adjacent normal aortic segment.
•Post-traumatic pseudoaneurysm
•Post-surgical pseudoaneurysm
•Saccular aneurysm
•Contained rupture
•Penetrating ulcer

Exclusion Criteria

•The stent graft would have to be positioned such that there would be no flow to an artery, major branch artery or major branch arteries which supply the spinal cord.
•The patient has congenital abnormalities in which the placement of the stent graft will cause occlusion of major arterial flow. Such abnormalities should be evaluated prior to treatment.
•Patient is pregnant.
•Patient is morbidly obese or has other clinical conditions that severely inhibit X-ray visualization of the aorta.
•Patient has connective tissue disease.
•Patient has a hypercoagulability disorder.
•Patient is in acute renal failure.
•Patient has active systemic infection.
•Patient is less than 18 years old.
•Patient has less than a one-year life expectancy.