Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thorac… (NCT00597870) | Clinical Trial Compass
CompletedNot Applicable
Physician-Sponsored IDE for the Talent Endoluminal Stent Graft System for the Treatment of Thoracic Lesions
United States304 participantsStarted 2002-05
Plain-language summary
The primary objective of this trial is to determine whether the Talent Thoracic Stent Graft, an investigational device, is a safe and effective method of treating thoracic aortic aneurysms (abnormal ballooning of the vessel wall) and other thoracic lesions (dissections, transections, pseudoaneurysms, penetrating ulcers, etc.). The endovascular method is a substitute for the major operation that is performed to treat the lesions.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Subjects who participate in this study as study patients must fulfill the following criteria:
* 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 Medtronic/Talent 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 peripheral…
What they're measuring
1
Number of Participants With Successful Endoluminal Treatment of Thoracic Lesion
Timeframe: Throughout study completion, an average of 1 year