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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT02990156
Eligibility Criteria:
Inclusion Criteria:
1. Male or female ≥18 years old and ≤80 years old at the time of signing the informed consent;
2. Intracranial ruptured or unruptured, single, previously untreated, saccular aneurysm diagnosed by CTA, MRA, DSA or other similar neuroimaging examination;
3. The maximum diameter of target aneurysm ≤24mm;
4. Baseline modified Rankin score (mRS) ≤2 points;
5. Baseline Hunt - Hess scores of patients with ruptured aneurysm ≤ Ⅲ;
6. The target aneurysm can be embolized in one operation;
7. The patient or the patient's guardian signs the informed consent voluntarily and is willing to accept follow-up.
Exclusion Criteria:
1. Clear allergy, resistance or contraindication to antiplatelet drugs, anticoagulants, contrast agents and/or anesthetics.
2. Definite allergy to platinum, tungsten and/or any substances of coils.
3. Subjects who are not suitable for anesthesia or endovascular treatment, such as those suffering from severe respiratory system, liver and kidney diseases or coagulation disorders (such as hemophilia).
4. Target aneurysm parent vessel stenosis ≥70%.
5. Anatomy not appropriate for endovascular treatment due to severe intracranial vessel tortuosity or stenosis, or intracranial vasospasm not responsive to medical therapy.
6. The target aneurysm has previously received surgery or other endovascular treatment.
7. Ruptured aneurysm requiring stent-assisted embolization.
8. The target aneurysm is hemangioid aneurysm, dissected aneurysm, fusiform aneurysm, infectious aneurysm, pseudoaneurysm, or arteriovenous malformation, or aneurysm associated with Moyamoya disease.
9. Major surgery was performed within 30 days before enrollment, or surgery was planned within 90 days after enrollment.
10. Patients with active infection at puncture point or other serious infection are not suitable for endovascular treatment.
11. Illness with a potential risk of sudden death.
12. Subjects with intracranial space-occupying lesions (e.g., intracranial tumor, abscess, etc.) or who are receiving radiotherapy for their head and neck.
13. Long-term treatment with anticoagulant drugs (such as warfarin) is required.
14. Having cognitive impairment, psychiatric disorder or other medical condition that may affect the data evaluation or trial results.
15. Unable to understand the trial or has a record of noncompliance with medical advice.
16. Taking banned medicine.
17. Life expectancy less than 1 year, may not complete follow-up.
18. Women in pregnancy or lactation, or women with positive pregnancy test.
19. Subjects who are participating in clinical trials of other drugs or devices and have not reached the end point of the trial, or are expected to participate in clinical trials of other drugs or devices.
20. Investigators do not consider it appropriate to participate in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02990156
Study Brief:
Protocol Section:
NCT02990156