Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-24 @ 7:00 PM
NCT ID:
NCT06256757
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06256757
Study Brief:
Protocol Section:
NCT06256757