Chronic Stanford B Type Aortic Dissection Proximal Tear Clinical Trial
Official title:
Guo's Entry Tear Repair :The First in Man Study of Endopatch System
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.
| Status | Recruiting |
| Enrollment | 27 |
| Est. completion date | December 15, 2023 |
| Est. primary completion date | December 15, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | Chinese PLA General Hospital | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Hangzhou Endonom Medtech Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | No major adverse events within 30 days after surgery. | Major adverse events within 30 days after operation refer to all-cause death, myocardial infarction, ischemic stroke, respiratory failure, liver failure, renal failure, intestinal necrosis, paraplegia, and amputation within 30 days after operation. Among them, renal failure refers to long-lasting dialysis, kidney transplantation, or other fatal results. Intestinal necrosis is intestinal ischemia that requires bowel resection or other fatal consequences. Severe lower limb ischemia refers to new severe limp or resting pain after surgery. | 30 days after operation | |
| Primary | The success rate of entry tears closure 6 months after operation. | The success rate of intimal tears closure at 6 months is a composite index, including immediate technical success after the operation and no leakage of the intimal tears sealed by the DSA 6 months after the operation, no displacement of the patch, and no second occurrence during the follow-up period. | 6 months after operation | |
| Secondary | All-cause mortality, aortic dissection-related mortality, serious adverse events, and device-related adverse events. | All-cause mortality 30 days, 6 months, and 12 months after operation;
Mortality related to aortic dissection 30 days, 6 months, and 12 months after operation; Incidence of serious adverse events 30 days, 6 months, and 12 months after operation; Incidence of device-related adverse events 30 days, 6 months, and 12 months after operation. |
30 days, 6 months, and 12 months after operation | |
| Secondary | False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation | False lumen thrombosis of the descending thoracic aorta 1 month, 6 months, 12 months after operation. | 1 month, 6 months, 12 months after operation | |
| Secondary | Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation | Change of false lumen diameter in descending thoracic aorta 1 month, 6 months, 12 months after operation. | 1 month, 6 months, 12 months after operation |