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| Name | Class |
|---|---|
| Stryker Neurovascular | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target 360°, 2D, Nano Coils | Subjects will undergo embolization using Target 360°, 2D, Nano Coils for the treatment of their intracranial aneurysm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Target 360°, 2D Coils, Nano Coils | Device |
|
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All sequential patients presenting with unruptured and ruptured saccular aneurysms, who meet all eligibility criteria, will be considered for study enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Victoria J Calderon, MPH | Contact | 4192514367 | vcalderon@mercy.com |
| Name | Affiliation | Role |
|---|---|---|
| Osama O Zaidat, MD, MS | Mercy Health St. Vincent Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Recruiting | Phoenix | Arizona | 85006 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31338061 | Derived | Zaidat OO, Castonguay AC, Rai AT, Badruddin A, Mack WJ, Alshekhlee AK, Shah QA, Hussain SI, Kabbani MR, Bulsara KR, Taqi AM, Janardhan V, Patterson MS, Nordhaus BL, Elijovich L, Puri AS. TARGET(R) Intracranial Aneurysm Coiling Prospective Multicenter Registry: Final Analysis of Peri-Procedural and Long-Term Safety and Efficacy Results. Front Neurol. 2019 Jul 9;10:737. doi: 10.3389/fneur.2019.00737. eCollection 2019. |
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| ID | Term |
|---|---|
| D002532 | Intracranial Aneurysm |
| ID | Term |
|---|---|
| D020765 | Intracranial Arterial Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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 |
| Tallahassee Neurological Clinic | Recruiting | Tallahassee | Florida | 32308 | United States |
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| Presence Saint Joseph Medical Center | Recruiting | Joliet | Illinois | 60435 | United States |
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| University of Massachusetts Medical School | Recruiting | Worcester | Massachusetts | 01655 | United States |
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| McLaren Health | Recruiting | Flint | Michigan | 48532 | United States |
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| SSM DePaul Health Center | Recruiting | St Louis | Missouri | 63132 | United States |
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| Mercy Health St. Vincent Medical Center | Recruiting | Toledo | Ohio | 43604 | United States |
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| Greenville Health System | Recruiting | Greenville | South Carolina | 29605 | United States |
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| West Virginia University Hospital | Recruiting | Morgantown | West Virginia | 26505 | United States |
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| D009422 | Nervous System Diseases |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |