Clinical Trial: TARGET Intracranial Aneurysm Coiling Registry

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Mercy Health, Ohio

Current Primary Outcome: Packing Density [ Time Frame: At immediate post-procedure (Day 1) ]

Packing density will be calculated based on aneurysm volume and amount of coil used during the embolization procedure.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Occlusion Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3-9 month follow-up ]
  • Aneurysm Re-treatment Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: Mercy Health, Ohio

Dates:
Date Received: December 7, 2012
Date Started: February 2013
Date Completion: April 2018
Last Updated: December 13, 2016
Last Verified: December 2016