Endovascular Coiling Using Target Tetra® Coils for Small Intracranial Aneurysm

Intracranial Aneurysm Clinical Trial

Official title: Safety and Efficacy of Endovascular Coiling Using Target Tetra® Coils for Small Intracranial Aneurysm: Prospective, Open-label, Single Arm, Single Center Study

Status Not yet recruiting

Clinical Trial 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).

Clinical Trial 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). 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. ;

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm

• NCT number: NCT06064435
• Study type: Observational
• Source: Yonsei University
• Contact: Keunyoung PARK, M.D.PhD.
• Phone: +82-2-2228-2150
• Email: kypark78.md@gmail.com
• Status: Not yet recruiting
• Start date: December 2023
• Completion date: March 2026