NCT01033214

ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

A Phase I Feasibility Study of the TAArget Thoracic Stent Graft for the Treatment of Aneurysms in the Descending Thoracic Aorta

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Duke Vascular, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the safety and effectiveness of endovascular repair with the LeMaitre TAArget thoracic stent graft as an alternative to open surgical repair.

Detailed description

* Subject is \> 18 years of age. * Females subjects must be either documented post-menopausal, surgically incapable of bearing children, or for women of childbearing potential, using barrier contraceptive methods and must have a negative serum pregnancy test at screening. * Subject is a candidate for endovascular thoracic aortic repair. * Subject has a TAA that meets one of the following criteria: * Is diagnosed with a Fusiform Focal TAA \>5cm, or * Is diagnosed with a Fusiform Focal TAA that has a diameter \< 5 cm and has exhibited rapid expansion, or * Is diagnosed with a Fusiform Focal TAA that has a diameter ≥ 4.5 cm and is at least twice the size of the normal DTA, or * Is diagnosed with a saccular TAA of any size.

Conditions

• Thoracic Aortic Aneurysm

Interventions

Type	Name	Description
DEVICE	Endovascular repair of TAA in the descending Thoracic Aorta	Usage of the TAArget thoracic stent graft for treatment of TAA in the Descending Thoracic Aorta.

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-06-01
• Completion: 2015-12-01
• First posted: 2009-12-16
• Last updated: 2015-05-20

Locations

2 sites across 1 country: United States