Endovascular Coiling Using Target Tetra® Coils for Small Intracranial Aneurysm

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.