Clinical Study of Thoracic Aortic Aneurysm Exclusion

Status unconfirmed · Not applicable

Conditions studied: Thoracic Aortic Aneurysm

In brief

The Valiant stent-graft system is a flexible, implantable vascular stent-graft endoluminal device preloaded in a delivery system that is used to exclude thoracic aortic lesions (thoracic aneurysms, thoracic dissections, penetrating ulcers, traumatic transections and both traumatic and degenerative pseudoaneurysms.

Key facts

Study ID

NCT00549315

Run by

Arizona Heart Institute

People needed

60

Starts

2002-10-01

Expected to finish

2012-09-01

Last updated by the study team

2009-05-15

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is ≥ 18 years of age.
• Subject is not pregnant or lactating. Females of child-bearing potential must practice a reliable method of contraception.
• Subject is diagnosed with one of the following conditions of the descending thoracic aorta. All conditions must be verified by diagnostic imaging [ultrasonography, computed tomography (CT), magnetic resonance imaging (MRI) or angiography].
• A true (i.e., atherosclerotic) supraceliac aneurysm (fusiform or saccular type) with or without a co-existing aortic dissection or penetrating aortic ulcer;
• Aortic dissection of DeBakey Type I or II (Stanford A, proximal) in the absence of an aneurysm; or
• Penetrating aortic ulcer in the absence of an aneurysm; or
• Traumatic transection; or
• Pseudoaneurysm - traumatic or degenerative (i.e., one that does not involve all layers of the vessel and is not atherosclerotic in origin.
• Subject's anatomy is suitable for placement of the TALENT endoluminal stent-graft, with a distinct proximal aneurysm neck of 10 mm or more in length and a distal aneurysm neck of at least 10 mm.
• Subject has a TAA that is dilated to ≥ 5 cm in diameter, ≥ 1.5 times the diameter of the adjacent native/non-aneurysmal aorta, or is symptomatic.
• Subject has a proximal and distal aortic neck diameter ≥ 18 mm and ≤ 42 mm.
• Subject has an arterial access site, either peripherally or via infrarenal abdominal aorta that is adequate for introduction of the stent-graft delivery system.
• Subject has signed the informed consent.
• Subject will be available for the periodic follow-up (surveillance) after the procedure.
• Aortic.

You may not qualify if…

• Subject has TAA with less than 10 mm proximal fixation length.
• Subject has an aneurysm that would require exclusion by the stent-graft of the segment of the aorta that gives rise to dominant spinal cord/intercostal arteries.
• Subject has a lesion that prevents delivery or expansion of the device.
• Subject has systemic infection, or is suspected of having systemic infection.
• Subject has a known mycotic aneurysm.
• Subject is not available or is not willing to come back for periodic follow-up (surveillance) after the procedure.

Where it is running

• Arizona Heart Institute — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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