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). The study is not designed as intervention or treatment study. The investigators will enroll up to 100 participants at the single center.
* Enrollment of patients: The following process is carried out for patients who have consented to participate in the study among non-ruptured or ruptured cerebral aneurysm patients selected based on the inclusion and exclusion criteria.
* Before the procedure, the following items are verified:
* Informed consent form
* Demographic information
* Past medical history and family history
* Vital signs
* Electrocardiogram (ECG) results (results from within the previous 12 weeks before the screening visit can be used)
* Laboratory test results (results from within the previous 12 weeks before the screening visit can be used): WBC, RBC, Hb, Hct, platelet count, PT INR, aPTT, cholesterol, ALP, AST, ALT, albumin, total bilirubin, total protein, BUN, creatinine, eGFR\*, Urine-HCG†, FBS, triglycerides, LDL, PRU (VerifyNow test), and ARU (VerifyNow test) \*eGFR = (140 - age) x (weight/72) x Creatinine
* Pregnancy test (if applicable)
* Imaging findings (results from within the previous 1 year before the screening visit can be used)
* Adverse events
* Concomitant medications/therapies
* Pre-procedure modified Rankin Scale (mRS) assessment
③ Following the established method, coil embolization is performed under general anesthesia, and mechanical or technical failures of the Target Tetra® Detachable Coil occurring during the treatment are investigated.
* Failure to advance or insert
* Stretch
* Disconnection
* Detachment failure
* Material deformation
* Difficult to remove
* Peeled or delaminated device
* Premature detachment ④ During the procedure and within 30 days post-procedure, neurological and non-neurological complications are investigated.
* Neurological complications
-Any cause of death
* Any intracranial thromboembolism (asymptomatic or symptomatic)
* Any intracranial hemorrhage including aneurysm perforation
* Any intracranial vessel injury
* Miscellaneous: any ocular hemorrhage
* Non-neurological complications
-Puncture site complication requiring any intervention
-Pseudoaneurysm
-Arteriovenous (AV) fistula
-Hematoma requiring transfusion
-Retroperitoneal hemorrhage
-Arterial dissection
* Thromboembolism including limb ischemia
* Miscellaneous: infection, vessel rupture/perforation
* Complications related to general anesthesia
* After the procedure, the occlusion rate of cerebral aneurysms (modified Raymond Scale; complete occlusion, neck remnant, sac remnant) and packing density are evaluated.
* Modified Raymond Scale
* Packing Density Packing Density = Volume of coils placed in the aneurysm / Volume of the aneurysm measured on a 3D workstation (%) The above process is conducted through the open-source Angiosuite application.
⑥ Characteristics of cerebral aneurysms in patients who have been treated with Target Tetra® Detachable Coils in over 70% of the total packing density are identified.
⑦ Clinical outcomes (mRS) are evaluated at 1 month, 6 months, 12 months of follow-up.
\<Modified Rankin Scale score\>
⑧ At 6 months, 12 months, the occlusion rate of cerebral aneurysms (Modified Raymond Scale) and recurrence are assessed by at least two neurosurgery specialists using 3T-MR angiography or cerebral angiography.
⑨ Patients who have not been treated with Target Tetra® Detachable Coils in over 70% of the total packing density are excluded from the analysis.
The independent Study Monitoring will be regularly proceed and processed on the basis of the permission of instituitional review board.
