Stanford Type B aortic dissection
Conditions
Interventions
Test Group:Talos Thoracic stent graft system
Sponsors
Fuwai Hospital Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria (Included if all the following criteria have been met): (1)Subjects aged 18 to 85 years who are not pregnant or lactating; (2)Subjects diagnosed with Stanford Type B aortic dissection; (3)Effective vascular landing zone of 15 mm proximal to the lesion; (4)Artery vessels qualified for access; (5)Subjects appropriate for endovascular treatment as judged by the investigator; (6)Subjects appropriate for open surgical treatment as judged by the investigator; (7)Subjects who can understand the purpose of the trial, voluntarily participate in the trail and sign the informed consent form, and are willing to be followed up.
Exclusion criteria
Exclusion criteria: Not included if any of the following criteria is met) (1)Subjects diagnosed with Stanford Type A aortic dissection; (2)Serious stenosis or calcification in the proximal landing zone of the stent may easily lead to the difficult of sticking to the vessel wall for the stent-graft; (3)Subjects who plan to be treated with the "chimney" technique during surgery; (4)Subjects with connective tissue disorders such as Marfan’s syndrome; (5)Subjects with infectious aortic dissection; (6)Subjects with combined abdominal aortic aneurysm and requiring recent intervention; (7)Subjects with uncontrolled serious infection and associated septicopyemia, shock or multiple organ failure; (8)Subjects who cannot tolerate anesthesia; (9)Subjects with a history of active bleeding, blood coagulation disorders or refusal of blood transfusion; (10)Subjects whose preoperative creatinine is 2.5 times higher than the upper limit of normal value; (11)Subjects with serious lesions such as liver failure; (12)Subjects allergic to contrast media, nitinol, and other stent materials; (13)Subjects who participate in other clinical trials during the same period; (14)Subjects who are pregnant, lactating or planning to conceive during the trial; (15)Subjects whose life expectancy is less than 12 months (such as advanced malignant tumors).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of 30-day major adverse events;12-month treatment success rat; | — |
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate;30-day all-cause mortality rat;The incidence of Endoleak;Diameters and diameter changes of aortic dissection and true and false lumens;aortic remodeling rate;Incidence of neurological ischemic complications;Incidence of visceral ischemic complications;Mortality rate associated with aortic dissection;All-cause mortality rate;Rate of conversion to open surgery;Device-related adverse event rate; | — |
Countries
China
Contacts
Public ContactChang Shu
Fuwai Hospital Chinese Academy of Medical Sciences
Outcome results
None listed