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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Successful Endoluminal Treatment of Thoracic Lesion
Timeframe: Throughout study completion, an average of 1 year