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 @ 11:48 PM
Ignite Modification Date:
2025-12-24 @ 11:48 PM
NCT ID:
NCT07141251
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosed with Crawford type III-IV thoracoabdominal aortic aneurysm or complex abdominal aortic aneurysm, with a healthy proximal landing zone (\>20mm length, angulation \<60°) in the descending aorta and maximum aneurysm diameter ≥4cm
2. Scheduled for endovascular aortic repair with commercially available iliac branch devices for visceral artery reconstruction
3. Signed informed consent and committed to protocol-defined follow-up
Exclusion Criteria:
1. Acquired language barrier, intellectual decline, cognitive impairment, or mental illness preventing informed consent
2. Uncontrolled autoimmune diseases (e.g., Takayasu arteritis, systemic lupus erythematosus, vasculitis)
3. Prior aortic surgery with stent-graft or prosthetic vascular graft implantation
4. End-stage renal/hepatic/cardiac/pulmonary failure or malignancy diagnosed within 5 years, likely to cause mortality during follow-up
5. Active bleeding or coagulopathy within 6 months (high bleeding risk)
6. Uncontrolled hypertension (resting SBP \>180 mmHg or DBP \>110 mmHg)
7. Uncontrolled diabetes (fasting blood glucose \>16.7 mmol/L)
8. Severe hepatic/renal dysfunction (serum creatinine \>3 mg/dL, ALT/AST \>3×ULN)
9. Concurrent participation in other interventional clinical trials
10. Pregnancy or perinatal status
11. Refusal to sign informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07141251
Study Brief:
Protocol Section:
NCT07141251