Aortic Dissection Aneurysm
Conditions
Brief summary
This trial aims to demonstrate the safety and validity of extracorporeal fenestration and in situ fenestration in patients with aortic disease involving the left subclavian artery.
Interventions
PROCEDUREfenestration
Thoracic EndoVascular Aortic Repair (TEVAR) with fenestrations
Sponsors
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
(All of the following criteria were met for enrolment): 1. Patients aged greater than 18 years old and less than 80 years old. 2. Patients diagnosed with thoracic aortic disease, including thoracic aortic dissection, thoracic aortic aneurysm, thoracic aortic ulcer and intramural hematoma. 3. Patients needed endovascular repair (TEVER). 4. Patients who needed complete coverage of the left subclavian artery (planned landing Zone was in Zone 2 of the aortic zone). 5. The proximal lesion involved the proximal aorta within 1.5cm of the posterior edge of the left subclavian artery (LSA) opening, but not the left common carotid artery (LCCA). 6. Suitable femoral artery, iliac artery and brachial artery access can be used for endovascular treatment. 7. The patients could understand the purpose of the study, volunteered to participate in the study, and informed consent was signed by the subjects themselves or their legal representatives. 8. Patients were willing to undergo follow-up evaluation as required by the study protocol. 9. The life expectancy of the patient is more than 12 months.
Exclusion criteria
(If any of the following criteria is met): 1. The lesion involved the proximal aorta of the LCCA opening (Zone 0 and Zone 1). 2. The patient has a definite connective tissue disease (e.g., Marfan syndrome). 3. The subjects had a history of previous thoracic endovascular aortic repair (TEVAR). 4. Patients who have had or may have had severe allergic reactions to contrast media (anaphylactic shock, exfoliative dermatitis, etc.). 5. Patients with contraindications to antiplatelet and anticoagulant drugs. 6. The patient's compliance was poor and the follow-up could not be expected on time. 7. Patients with acute systemic infection. 8. Patients cannot tolerate general anesthesia. 9. Patients judged by the investigator to be ineligible for endovascular treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| all-cause mortality | 1 month postoperative | all-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of secondary intervention | postoperative (1, 6，12 months) | incidence of secondary intervention |
| incidence of major adverse events (MAE) | postoperative (1, 6，12 months) | incidence of major adverse events (MAE) |
| immediate technical success rate | immediate postoperative | immediate technical success rate |
| all-cause mortality | postoperative (6, 12 months) | all-cause mortality |
| incidence of endoleak | postoperative (1, 6，12 months) | incidence of endoleak |
Contacts
Primary ContactYanbo Lou
Outcome results
None listed