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 range18 Years – 80 Years
SexALL
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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);
✕. 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;
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.