Clinical trial NCT04745039: Guo's Entry Tear Repair :The First in Man Study of Endopatch System
Official title: Guo's Entry Tear Repair :The First in Man Study of Endopatch System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Stanford B Type Aortic Dissection Proximal Tear
Lead sponsor: Hangzhou Endonom Medtech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patients aged 18 to 80 years old, no gender limitation;
2. 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;
3. Diagnosed as chronic Stanford type B aortic dissection;
4. Maximum diameter of the intimal tears is between 2mm and 20mm;
5. Important branch vessels will not be covered after intimal tears closure;
6. Aortic endovascular treatment can be performed with appropriate arterial access.

Exclusion Criteria:

1. Diagnosed as acute, subacute aortic dissection;
2. Intermural hematoma, aortic ulcer, pseudoaneurysm, and severe aortic calcification;
3. 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);
4. Pregnant, breastfeeding or cannot contraception during the trial period;
5. Participated in clinical trials of other drugs or devices during the same period;
6. 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;
7. Allergic to contrast agents, anesthetics, patches, and delivery materials;
8. Cannot tolerate anesthesia;
9. Severe liver, kidney, lung, and heart function abnormalities before surgery \[Serum creatinine exceeds 2 times the upper limit of normal; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) exceeds 5 times the upper limit of normal; Serum total bilirubin (STB) more than 2 times the upper limit of normal; Left ventricular ejection fraction is lower than normal by cardiac color Doppler ultrasound examination\];
10. History of myocardial infarction, TIA or cerebral infarction within the past 3 months;
11. Life expectancy is less than 12 months (such as advanced malignant tumors)
12. Acute systemic infection
13. Investigator judged that not suitable for interventional treatment.

Primary outcomes:
measure: No major adverse events within 30 days after surgery.
timeFrame: 30 days after operation
measure: The success rate of entry tears closure 6 months after operation.
timeFrame: 6 months after operation
Secondary outcomes:
measure: All-cause mortality, aortic dissection-related mortality, serious adverse events, and device-related adverse events.
timeFrame: 30 days, 6 months, and 12 months after operation
measure: False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation
timeFrame: 1 month, 6 months, 12 months after operation
measure: Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation
timeFrame: 1 month, 6 months, 12 months after operation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References: