Intracranial Aneurysms
Conditions
Keywords
intracranial aneurysm, cerebral aneurysm, packing density, Target Coils, aneurysm embolization
Brief summary
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.
Interventions
DEVICETarget 360°, 2D Coils, Nano Coils
Sponsors
Stryker Neurovascular
Mercy Health Ohio
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is 18 years or older. 2. Patient has a documented, previously untreated, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils. 3. (NEW NANO arm ONLY) Target aneurysm is ≤7mm. 4. Patient has a Hunt and Hess Score of 3 or less. 5. Patient has a premorbid mRS of 3 or less. 6. Patient or patient's legally authorized representative has provided written informed consent. 7. Patient is willing to and can comply with study follow-up requirements.
Exclusion criteria
1. Patient is \< 18 years old. 2. Dissecting aneurysm. 3. Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up). 4. 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. 5. (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. 6. Target aneurysm is fusiform. 7. Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Packing Density | At immediate post-procedure (Day 1) | Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aneurysm Re-access Rate | At end of study procedure (Day 1) | The rate of re-assess (Microcatheter kick-back rate) of the target aneurysm will be captured during the procedure. |
| Time of Fluoroscopic Exposure | At immediate post-procedure (Day 1) | 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. |
| Overall Procedure Time | At Immediate post-procedure (Day 1) | The overall procedure time will be captured from the time of guide catheter placement to the end of the coil embolization procedure. |
| Aneurysm Recurrence | 3-9 month follow-up | — |
| Aneurysm Re-treatment Rate | 3-9 month follow-up | Aneurysm re-treatment rates will be tracked and recorded during the 3-9 month follow-up |
| Occlusion Rate | At immediate post-procedure (Day 1) and 3-9 month follow-up | Angiographic occlusion of the aneurysm will be adjudicated by an independent core lab using immediate post-procedure and 3-9 month follow-up angiography. |
| Treatment-related Morbidity and Mortality | from study procedure (Day 1) to 3-9 month follow-up | Treatment-related morbidity and morality will be tracked and recorded from study procedure through the 3-9 month follow-up. |
| Modified Rankin Score | At baseline (Day 1) and hospital discharge (Day 3) and 3-9 month follow-up | Modified Rankin score will be recorded at baseline, hospital discharge, and during the 3-9 month follow-up. |
| Device-related serious adverse events | From the study procedure (Day 1) until 3-9 month follow up | 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. |
| Length of hospital stay | At hospital discharge (Day 3) | Length of hospital stay will be recorded at the time of patient discharge. |
| Technical and clinical endpoints of Target 360° and 2D coils | 3-9 month follow-up | A post hoc analysis comparing Target 360° and 2D coil primary and secondary technical and clinical endpoints will be performed upon final data analysis. |
| Aneurysm Bleed and Re-bleed Rate | 3-9 month follow-up | Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up. |
Countries
United States
Contacts
Primary ContactVictoria J Calderon, MPH
Outcome results
None listed