TARGET Intracranial Aneurysm Coiling Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Target 360°, 2D, Nano Coils Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm. |
Device: Target 360°, 2D Coils, Nano Coils
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient is 18 years or older.
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Patient has a documented, previously untreated, saccular intracranial aneurysm, unruptured or ruptured, suitable for embolization with coils.
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(NEW NANO arm ONLY) Target aneurysm is ≤7mm.
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Patient has a Hunt and Hess Score of 3 or less.
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Patient has a premorbid mRS of 3 or less.
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Patient or patient's legally authorized representative has provided written informed consent.
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Patient is willing to and can comply with study follow-up requirements.
Exclusion Criteria:
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Patient is < 18 years old.
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Dissecting aneurysm.
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Patients with intracranial aneurysms (other than the target aneurysm) that will require treatment during the study period (enrollment through follow-up).
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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.
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(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.
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Target aneurysm is fusiform.
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Patients in which the target aneurysm cannot be coiled in one procedure (i.e. staged procedure)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arizona | Phoenix | Arizona | United States | 85006 |
| 2 | Tallahassee Neurological Clinic | Tallahassee | Florida | United States | 32308 |
| 3 | Presence Saint Joseph Medical Center | Joliet | Illinois | United States | 60435 |
| 4 | University of Massachusetts Medical School | Worcester | Massachusetts | United States | 01655 |
| 5 | McLaren Health | Flint | Michigan | United States | 48532 |
| 6 | SSM DePaul Health Center | Saint Louis | Missouri | United States | 63132 |
| 7 | Mercy Health St. Vincent Medical Center | Toledo | Ohio | United States | 43604 |
| 8 | Greenville Health System | Greenville | South Carolina | United States | 29605 |
| 9 | West Virginia University Hospital | Morgantown | West Virginia | United States | 26505 |
Sponsors and Collaborators
- Mercy Health Ohio
- Stryker Neurovascular
Investigators
- Principal Investigator: Osama O Zaidat, MD, MS, Mercy Health St. Vincent Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 19180