Distal tear after aortic repair surgery
Conditions
Interventions
Test group:Biodegradable Aortic Occluder System
Control group:Conservative treatment measures
Learning Curve Group:Biodegradable Aortic Occluder System
Sponsors
First Medical Center of the General Hospital of the Chinese People's Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years, with no gender restriction; 2. Presence of residual dissection after Sun's surgical procedure for type A aortic dissection or TEVAR for type B aortic dissection; 3. Maximum diameter of a single tear <=15 mm; 4. Participants who understand the purpose of the trial, voluntarily enroll in the study, sign an informed consent form by themselves or their legal representatives, and agree to complete the follow-up as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. The maximum diameter of the residual aortic dissection aneurysm is >5.5 cm; 2. Rapid growth of the residual aortic dissection aneurysm (>5 mm/6 months); 3. Complications such as retrograde dissection, endoleak, and anastomotic leak; 4. Signs of rupture or impending rupture of the residual aortic dissection; 5. The distance from the intimal tear to the margins of the celiac artery, superior mesenteric artery, and renal artery openings is =5 times the upper limit of normal and/or end-stage renal disease requiring dialysis; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal; serum total bilirubin (T-Bil) >5 times the upper limit of normal); 12. Subjects with severe bleeding, coagulopathy, or any other uncontrollable bleeding disorders; 13. Subjects who have experienced a myocardial infarction within the past 3 months; 14. Subjects known to be allergic to contrast agents, anesthetics, or trial device materials; 15. Subjects for whom no suitable arterial access for endovascular aortic treatment is identified via imaging evaluation; 16. Subjects with an expected survival time <12 months (e.g., advanced malignancy); 17. Subjects requiring concurrent surgery to address other vascular diseases (e.g., coronary, renal, or superior mesenteric arteries); 18. Patients requiring the use of other endovascular aortic repair and branch vascular endovascular treatment devices simultaneously; 19. Pregnant or lactating female subjects, or female subjects planning to become pregnant during the trial; 20. Subjects currently participating in other drug or medical device clinical trials; 21. Subjects deemed unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the volume of the descending aorta; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immediate technical success rate;Success rate of remote rupture closure;Changes in the true lumen volume of the diseased segment of the descending aortic dissection;Changes in false lumen volume of the dissected segment of descending aorta;Changes in thrombus volume in the diseased segment of the descending aortic dissection;Maximum diameter change in the aortic dissection lesion segment;Changes in the maximum diameter of the false lumen in the diseased segment of the descending aortic dissection;Changes in the minimum diameter of the true lumen of the dissected aortic segment;Incidence rate of secondary intervention;Incidence of major adverse events;Incidence of embolic device dislodgement;All-cause mortality;Mortality associated with descending aortic dissection;Incidence of adverse events;Incidence of serious adverse events;Device defect incidence rate; | — |
Countries
China
Contacts
Public ContactWei Guo
First Medical Center of the General Hospital of the Chinese People's Liberation Army
Outcome results
None listed