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 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT06416657
Eligibility Criteria:
Inclusion Criteria:
1. Age ≥18 years old and ≤80 years old, gender is not limited;
2. Patients with previously untreated unruptured intracranial aneurysm (UIA) clearly diagnosed by DSA, CTA, or MRA;
3. UIA maximum diameter \<15mm;
4. Baseline mRS score ≤2;
5. UIAs planned for treated with PED;
6. Patients voluntarily participated in this study and signed an informed consent form.
Exclusion Criteria:
1. The aneurysms are located distal to the anterior cerebral artery (including the anterior communicating artery), distal to the M2 segment of the middle cerebral artery, and distal to the basilar artery;
2. Those who are allergic to any components of the anesthetic drugs;
3. Severe symptoms associated with the target aneurysm at the time of diagnosis, with mRS score ≥3;
4. Pregnant and lactating female patients;
5. Severe hepatic dysfunction (ALT or AST \>three times the normal upper limit) or severe renal dysfunction (creatinine clearance rate \<30 mL/min) before randomisation;
6. Patients with metal implants in the body (e.g., cardiac stents, cardiac prosthetic valves, pacemakers, metal joints, steel plates, non-removable metal dentures, etc.);
7. Patients known to suffer from dementia or psychiatric diseases and claustrophobia can not complete the magnetic resonance examination;
8. Patients with other serious diseases combined at the time of diagnosis with an expected survival time of less than 1 year;
9. Patients who are participating in clinical trials of other drugs or devices;
10. Other conditions that, in the judgment of the investigator, exist that are unsuitable for enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06416657
Study Brief:
Protocol Section:
NCT06416657