Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair (NCT03347812) | Clinical Trial Compass
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Clinical Study for Evaluating the Safety and Efficacy of Total Endovascular Aortic Arch Repair
China400 participantsStarted 2017-11-22
Plain-language summary
Aortic disease is a kind of cardiovascular diseases with very high mortality rate and high risk of surgical treatment. At present, the surgical and endovascular treatment for diseases in the ascending aorta, descending aorta and abdominal aorta are becoming more and more mature. However, due to the complexity of the aortic arch in anatomy, function and pathological changes, the optimal treatment strategy for diseases in the aortic arch has been controversial constantly.
This research is a multi-center(four centers), prospective, controlled, large-scale (about 400 subjects) clinical study, using traditional thoracic surgery of aortic arch disease as a control to verify that new techniques for endovascular treatment is not inferior to traditional thoracic surgery in terms of efficiency and safety.
Further more, the investigators plan to explore the indications of the application of these new techniques, develop a better diagnosis and treatment program, reduce the risk of such surgical treatment and the incidence of complications, improve clinical efficacy and the overall quality of the disease.
Who can participate
Age range
40 Years – 75 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:
* Patients have aortic arch lesions caused by atherosclerosis and hypertension, and are also suitable for both chimney/ fenestration / branch stent-grafts technique and total arch replacement surgery simultaneously.
* Lesions involve the aortic arch, at least one branch of the aortic arch to be revascularized.
* The type of lesion is dissection, aneurysm, pseudoaneurysm, or ulcer.
* Life expectancy is more than 1 year.
* Patients are able to understand the purpose of this trial, voluntarily attend and sign the informed consent form, and are willing to accept the specified follow-up at specific time point.
Exclusion Criteria:
* Patients had a stroke or ST-segment elevation myocardial infarction within 30 days prior to surgery.
* Patients underwent major surgery (grade 3 or above) or interventional therapy within 30 days prior to surgery.
* Patients will undergo any major elective surgery (grade 3 or above) or interventional therapy within 30 days after surgery.
* Patients had a previous thoracic aortic surgery in the past.
* Patients had previous thoracic aortic endovascular treatment, and the last implants had an effect on this procedure or had intersections with implants would be used in this procedure.
* Patients need intervention in other vascular lesions (such as coronary arteries, lower extremity arteries, carotid arteries) in the same procedure, or have heart disease and postoperative medication regimens are affected.
* Patients have hepatic and r…
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
No death within 30 days after surgery
Timeframe: 1 month after surgery for treating aortic arch disease performed
2
No adverse cardiovascular and cerebrovascular events within one year after surgery
Timeframe: 12 month after surgery for treating aortic arch disease performed
3
No reoperative intervention associated with aorta occurred within one year after surgery
Timeframe: 12 month after surgery
Trial details
NCT IDNCT03347812
SponsorChinese Academy of Medical Sciences, Fuwai Hospital