Guo's Entry Tear Repair :The First in Man Study of Endopatch System (NCT04745039) | Clinical Trial Compass
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Guo's Entry Tear Repair :The First in Man Study of Endopatch System
China27 participantsStarted 2021-04-15
Plain-language summary
A prospective, single-center, first in man study to evaluate the safety and efficacy of Endopatch System manufactured by Hangzhou Endonom Medtech Co., Ltd. for the Chronic Stanford B type aortic dissection proximal tear.
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
. Patients aged 18 to 80 years old, no gender limitation;
. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol;
. Diagnosed as chronic Stanford type B aortic dissection;
. Maximum diameter of the intimal tears is between 2mm and 20mm;
. Important branch vessels will not be covered after intimal tears closure;
. Aortic endovascular treatment can be performed with appropriate arterial access.
Exclusion criteria
. Diagnosed as acute, subacute aortic dissection;
. Intermural hematoma, aortic ulcer, pseudoaneurysm, and severe aortic calcification;
. The minimum distance between the intimal tears of the aortic intimal flaps and the root of the intimal flaps is less than the radius of the patch to be used (the patch cannot be deployed flat);
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 major adverse events within 30 days after surgery.
Timeframe: 30 days after operation
2
The success rate of entry tears closure 6 months after operation.
. Pregnant, breastfeeding or cannot contraception during the trial period;
. Participated in clinical trials of other drugs or devices during the same period;
. The same operation requires intervention in other vascular diseases (such as coronary artery, renal artery, superior mesenteric artery, etc.), and the postoperative drug treatment plan is therefore affected;
. Allergic to contrast agents, anesthetics, patches, and delivery materials;