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.
Study Type
OBSERVATIONAL
Enrollment
150
University of Arizona
Phoenix, Arizona, United States
RECRUITINGTallahassee Neurological Clinic
Tallahassee, Florida, United States
RECRUITINGPacking Density
Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure.
Time frame: At immediate post-procedure (Day 1)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Immediate post-procedure (Day 1)
Aneurysm Recurrence
Time frame: 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
Time frame: 3-9 month follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Presence Saint Joseph Medical Center
Joliet, Illinois, United States
University of Massachusetts Medical School
Worcester, Massachusetts, United States
RECRUITINGMcLaren Health
Flint, Michigan, United States
RECRUITINGSSM DePaul Health Center
St Louis, Missouri, United States
RECRUITINGMercy Health St. Vincent Medical Center
Toledo, Ohio, United States
RECRUITINGGreenville Health System
Greenville, South Carolina, United States
RECRUITINGWest Virginia University Hospital
Morgantown, West Virginia, United States
RECRUITINGAneurysm Bleed and Re-bleed Rate
Aneurysm Bleed and Re-bleed Rate will be assessed and recorded at the 3-9 month follow-up.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 3-9 month follow-up