ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01033214
Study type	Interventional
Source	Duke Vascular, Inc.
Contact
Status	Active, not recruiting
Phase	Phase 1
Start date	January 2010
Completion date	December 2015

View Details

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