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ENTRUST - TAArget® Thoracic Stent Graft Clinical Trial

2014-07-23 21:11:22 | BioPortfolio

Summary

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

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

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

Conditions

Thoracic Aortic Aneurysm

Intervention

Endovascular repair of TAA in the descending Thoracic Aorta

Location

Christiana Hospital
Newark
Delaware
United States
19713

Status

Not yet recruiting

Source

LeMaitre Vascular

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:11:22-0400

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Medical and Biotech [MESH] Definitions

An abnormal balloon- or sac-like dilatation in the wall of the THORACIC AORTA. This proximal descending portion of aorta gives rise to the visceral and the parietal branches above the aortic hiatus at the diaphragm.

The portion of the descending aorta proceeding from the arch of the aorta and extending to the DIAPHRAGM, eventually connecting to the ABDOMINAL AORTA.

The tearing or bursting of the wall along any portion of the AORTA, such as thoracic or abdominal. It may result from the rupture of an aneurysm or it may be due to TRAUMA.

Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.

An abnormal balloon- or sac-like dilatation in the wall of the ABDOMINAL AORTA which gives rise to the visceral, the parietal, and the terminal (iliac) branches below the aortic hiatus at the diaphragm.

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