Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 5:49 PM
Study NCT ID:
NCT06064435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-18
First Post:
2023-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endovascular Coiling Using Target Tetra® Coils for Small Intracranial Aneurysm
Sponsor:
Yonsei University
Organization:
Study Overview
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
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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). 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.
* 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: