aortic dissection, aortic pseudoaneurysm, aortic rupture
Conditions
Interventions
Test group:FixTA Tri-Branch
Sponsors
Beijing Anzhen Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–80 years (inclusive); sex not restricted. 2. The lesion involves or is adjacent to the aortic arch. 3. Imaging-confirmed anatomy meeting all of the following: • Suitable access via iliac/femoral artery, bilateral radial/brachial arteries, and left carotid artery; • A usable landing zone with diameter 26–45 mm and length >=15 mm; • Lesion morphology deemed by the investigator to be appropriate for treatment with the investigational device. 4. Meets any of the following: a. High-risk for open aortic arch surgery, including (but not limited to): preoperative malperfusion syndrome; history of myocardial infarction within 3 months prior to surgery; connective tissue disease; infection with sepsis, shock, or multi-organ dysfunction/failure; coagulopathy; malnutrition, etc. b. Deemed by two surgeons experienced in aortic arch surgery to be unsuitable for open surgery for other reasons. c. Other reasons for being unsuitable for open surgery (e.g., religious beliefs, or refusal of open surgical treatment despite adequate informed disclosure). 5. Able to understand the purpose of the trial, voluntarily participate, provide written informed consent, and willing to comply with follow-up.
Exclusion criteria
Exclusion criteria: 1. Uncontrolled severe infection and related sepsis, shock, or multiple organ dysfunction/failure. 2. Severe coagulopathy. 3. Malignancy or other serious disease with life expectancy =12 months. 4. Allergy/hypersensitivity to device materials or contrast media. 5. Pregnancy or lactation. 6. Participation in another clinical trial not yet completed. 7. Any other condition judged by the investigator to make the subject unsuitable for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Device implantation success;Stroke;Endoleak;Stent patency rate;False lumen / aneurysm sac thrombosis;Changes in true lumen and false lumen dimensions in aortic dissection;Stent-graft migration;New aortic entry tear and retrograde dissection;Conversion to open surgery;Additional endovascular or open surgical interventions (re-intervention);Target lesion-/disease-related mortality;Aortic rupture; | — |
Countries
China
Contacts
Public ContactChen Zhong
Beijing Anzhen Hospital, Capital Medical University
Outcome results
None listed