A Multi-center Trial of Single-Branched Stent Graft System to Treat Aortic Dissection (NCT01914237) | Clinical Trial Compass
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A Multi-center Trial of Single-Branched Stent Graft System to Treat Aortic Dissection
China70 participantsStarted 2013-04
Plain-language summary
Aim:Castor is a novel single-branched stent graft system for endovascular repair of aortic arch dissection. This is a prospective, one-arm, open, multi-center, pre-market study of Castor stent to evaluate its efficacy and safety in treatment of aortic dissection.
Number of patients: 70 patients will be included and undertaken endovascular repair with Castor stent.
Follow-up: 1.aortic computed tomographic angiography (CTA) examination 6 and 12 months after the surgery 2.telephone or clinical follow-up 30 days and 2-5 years after the surgery
Primary Outcome Measure: success rate of endovascular repair for efficacy measurement.
Secondary Outcome Measure: 1 year stent related adverse event rate for safety measurement.
Other Outcome Measures:
1. efficacy:
* 1 year success rate of treatment
* 1 year patency rate of branch stent
2. safety:
* in-hospital mortality
* complication rate of neural system
* 1 year dissection or stent related mortality
Who can participate
Age range
18 Years – 80 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:
* age from 18 to 80, male or unpregnant female
* diagnosed as aortic dissection
* proximal tear of the dissection locates between 15mm to the distal end of left common carotid artery and 20mm to the distal end of left subclavian artery (LSA) or inverse tear to LSA
* good compliance with the instructions and cooperate with follow-up
* voluntarily signed the informed consent form
Exclusion Criteria:
* Pregnant female
* no appropriate vessel approaches
* patients with connective tissue diseases (such as Marfan syndrome)
* allergic to nitinol or contrast medium
* bad compliance with the instructions and follow-up
* estimated remaining life is less than 12 months
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.