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 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT06064435
Eligibility Criteria:
Inclusion Criteria:
1. Adults aged 19 to 80 years
2. Patients with intracranial aneurysms suitable for endovascular embolization therapy with a maximum diameter of 5mm or less
3. Including both ruptured and unruptured intracranial aneurysms
4. Patients for whom the use of Target Tetra® coil is expected in endovascular coil embolization therapy
5. Patients who have undergone balloon-assisted coiling or adjunctive stent placement during coil embolization
6. Subjects who have received an explanation of the clinical study and provided written consent to participate in the study
Exclusion Criteria:
1. Age below 18 or above 81 years
2. Infectious, dissecting, traumatic, or mycotic aneurysms
3. Patients who have undergone surgical or endovascular treatment for the target intracranial aneurysm
4. Patients in whom vascular access to the target intracranial aneurysm is not possible due to conditions such as moyamoya disease, dural arteriovenous malformation, significant atherosclerotic stenosis, or severe vessel tortuosity
5. Patients with ruptured intracranial aneurysms classified as Hunt and Hess grade 5 (deep coma)
6. Patients with hypersensitivity reactions to the materials used in the coils, such as platinum, tungsten, nickel, or stainless steel
7. Patients with serious adverse reactions to contrast agents
8. Patients who are unable to complete planned follow-up observations due to expected short-term survival or comorbidities
9. Female patients who are pregnant (positive pregnancy test) or planning pregnancy within 12 months after coil placement, or breastfeeding
10. Patients with significant renal dysfunction or uncorrected coagulation disorders
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
80 Years
Study:
NCT06064435
Study Brief:
Protocol Section:
NCT06064435