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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT04765592
Eligibility Criteria:
Inclusion Criteria:
1. Patients aged 18 to 80 years old;
2. Diagnosed with aortic arch lesions requiring intervention, including true aortic arch aneurysms, pseudo-aortic arch aneurysms, and ulcers involving the aortic arch;
3. Showing a suitable vascular condition, including:
* Ascending aorta length greater than 50 mm (from the aortic sinusoid junction to the proximal cardiac margin of the innominate artery).
* Ascending aorta diameter ≥ 24 mm and ≤ 48 mm;
* Proximal anchoring zone length ≥ 30 mm;
* Innominate artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
* Left common carotid artery or left subclavian artery diameter ≤ 24 mm and ≥ 7 mm, length ≥ 20 mm；
* Suitable arterial access for endovascular interventional treatment;
4. Able to understand the purpose of the trial, participate in the trial voluntarily with informed consent form signed by the patient him/herself or his or her legal representative, and willing to complete follow-up visits as required under the protocol.
5. Evaluated by at least two vascular surgeons or cardiac surgeons as high surgical risk patients or deemed to have significant surgical contraindications.
Exclusion Criteria:
1. Experienced systemic infection during past three months;
2. Neck surgery was performed within 3 months;
3. Previous endovascular interventional treatment involving the aortic arch was performed;
4. Infectious aortic disease、Takayasu arteritis，Marfan syndrome (or other connective tissue diseases );
5. Severe stenosis, calcification, thrombosis, or tortuosity of the carotid or subclavian artery;
6. Heart transplant;
7. Suffered MI or stroke during past three months;
8. Class IV heart function (NYHA classification);
9. Active peptic ulcers or upper gastrointestinal bleeding occurring within the previous three months;
10. Hematological abnormality, defined as follows: Leukopenia (WBC \< 3 × 109/L), acute anemia (Hb \< 90 g/L); thrombocytopenia (PLT count \< 50 × 109/L), history of bleeding or coagulopathy;
11. Renal insufficiency， creatinine \> 265 umol/L (or 3.0mg/dL) and/or end-stage renal disease requiring renal dialysis, as determined by an investigator after a thorough analysis;
12. Pregnant or breastfeeding;
13. Allergies to contrast agents;
14. Life expectancy of less than 12 months;
15. Participating in another drug or device research;
16. Any other disease or abnormality that the investigators believe may hinder endovascular interventional treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04765592
Study Brief:
Protocol Section:
NCT04765592