TARGET Intracranial Aneurysm Coiling Registry

Study Overview
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Brief Summary
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The purpose of this prospective registry is to collect real world, post-marketing data on the use of Stryker Target® 360,Target® 2D, and 2nd generation Target® Nano coils for the embolization of ruptured or unruptured intracranial saccular aneurysms. Up to 300 patients (150 in the TARGET 360°/Helical arm and 150 in the New NANO arm) presenting with intracranial aneurysms suitable for coil embolization will be enrolled at up to 20 sites. A post hoc analysis comparing Target® 360° and Target® 2D coil technical and clinical endpoints will be performed.

Official Title
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TARGET Intracranial Aneurysm Coiling Registry: A Prospective Clinical Efficacy and Safety Study of Stryker Target® 360°, Target® Helical, and 2nd Generation Target® Nano Coils

Conditions
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Intracranial Aneurysms

Intervention / Treatment
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* Device: Target 360°, 2D Coils, Nano Coils


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is 18 years or older. Patient has a documented, previously untreated, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils. (NEW NANO arm ONLY) Target aneurysm is ≤7mm. Patient has a Hunt and Hess Score of 3 or less. Patient has a premorbid mRS of 3 or less. Patient or patient's legally authorized representative has provided written informed consent. Patient is willing to and can comply with study follow-up requirements. Exclusion Criteria: Patient is < 18 years old. Dissecting aneurysm. Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up). Patients in whom the target aneurysm will be treated with coils other than Stryker Target® 360°, Target® Helical coils, and 2nd generation Target® Nano Coils. (NEW NANO Arm ONLY) Patients in whom the target aneurysm was treated with a total coil length comprised of <25% Stryker Target® 2nd generation Nano Coils. Target aneurysm is fusiform. Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Target 360°, 2D, Nano Coils<br>Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm. | Device: Target 360°, 2D Coils, Nano Coils<br> <br> * Other names: Target Nano coil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Packing Density | Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure. | At immediate post-procedure (Day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occlusion Rate | Angiographic occlusion of the aneurysm will be adjudicated by an independent core lab using immediate post-procedure and 3-9 month follow-up angiography. | At immediate post-procedure (Day 1) and 3-9 month follow-up | 
| Aneurysm Re-access Rate | The rate of re-assess (Microcatheter kick-back rate) of the target aneurysm will be captured during the procedure. | At end of study procedure (Day 1) | 
| Time of Fluoroscopic Exposure | Total time of fluoroscopic exposure will be captured from the initial recording of the road map to the final angiogram after completion of the coil embolization procedure. | At immediate post-procedure (Day 1) | 
| Overall Procedure Time | The overall procedure time will be captured from the time of guide catheter placement to the end of the coil embolization procedure. | At Immediate post-procedure (Day 1) | 
| Aneurysm Recurrence |  | 3-9 month follow-up | 
| Aneurysm Re-treatment Rate | Aneurysm re-treatment rates will be tracked and recorded during the 3-9 month follow-up | 3-9 month follow-up | 
| Aneurysm Bleed and Re-bleed Rate | Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up. | 3-9 month follow-up | 
| Treatment-related Morbidity and Mortality | Treatment-related morbidity and morality will be tracked and recorded from study procedure through the 3-9 month follow-up. | from study procedure (Day 1) to 3-9 month follow-up | 
| Modified Rankin Score | Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up. | At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up | 
| Device-related serious adverse events | Procedural and post-procedural serious adverse events related to the device and/or procedure will be captured and recorded at the end of the procedure and until the patient has completed the 3-9 month follow-up. | From the study procedure (Day 1) until 3-9 month follow up | 
| Length of hospital stay | Length of hospital stay will be recorded at the time of patient discharge. | At hospital discharge (Day 3) | 
| Technical and clinical endpoints of Target 360° and 2D coils | A post hoc analysis comparing Target 360° and 2D coil primary and secondary technical and clinical endpoints will be performed upon final data analysis. | 3-9 month follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial aneurysm, cerebral aneurysm, packing density, Target Coils, aneurysm embolization