Status:
NOT_YET_RECRUITING
Endovascular Coiling Using Target Tetra® Coils for Small Intracranial Aneurysm
Lead Sponsor:
Yonsei University
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
19-80 years
Brief Summary
The goal of this study was to verify the safety and effectiveness of Target Tetra® Detachable Coil in the endovascular embolization treatment of small intracranial aneurysm (≤5mm).
Detailed Description
The study is a Prospective Single-arm Single-center Registry that aims to assess the safety and efficacy of the Target Tetra Coils in the endovascular treatment of small intracranial aneurysms (≤5mm)....
Eligibility Criteria
Inclusion
- Adults aged 19 to 80 years
- Patients with intracranial aneurysms suitable for endovascular embolization therapy with a maximum diameter of 5mm or less
- Including both ruptured and unruptured intracranial aneurysms
- Patients for whom the use of Target Tetra® coil is expected in endovascular coil embolization therapy
- Patients who have undergone balloon-assisted coiling or adjunctive stent placement during coil embolization
- Subjects who have received an explanation of the clinical study and provided written consent to participate in the study
Exclusion
- Age below 18 or above 81 years
- Infectious, dissecting, traumatic, or mycotic aneurysms
- Patients who have undergone surgical or endovascular treatment for the target intracranial aneurysm
- 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
- Patients with ruptured intracranial aneurysms classified as Hunt and Hess grade 5 (deep coma)
- Patients with hypersensitivity reactions to the materials used in the coils, such as platinum, tungsten, nickel, or stainless steel
- Patients with serious adverse reactions to contrast agents
- Patients who are unable to complete planned follow-up observations due to expected short-term survival or comorbidities
- Female patients who are pregnant (positive pregnancy test) or planning pregnancy within 12 months after coil placement, or breastfeeding
- Patients with significant renal dysfunction or uncorrected coagulation disorders
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06064435
Start Date
December 1 2023
End Date
March 1 2026
Last Update
December 18 2023
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea