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Study Title Principal Investigator
Rationale and Intervention:This is a prospective, single-arm, multi-center post-marketing data collection study to determine the safety and effectiveness of HyperSoft and HydroFrame/HydroSoft coils in the treatment of small intracranial aneurysms. HyperSoft Helical, HyperSoft 3 D and HydroFram/HydroSoft are newly designed coils where the shape and softness of these coils are designed for small aneurysms. There are 2 phases in this study. In Phase 1, participants will be enrolled if they will be treated with HyperSoft 3D and HyperSoft helical coils. When the sponsor adds phase 2, patients will be enrolled into Phase 2 if their aneurysm will be framed with HydroFrame HydroSoft 3D and finished with HyperSoft 3D and /or Hyper Soft helical coils. Objectives:The primary objective of this study is to assess clinical and imaging outcomes in the endovascular treatment of small ( 4.9 mm) intracranial aneurysms utilizing the HyperSoft 3D and HyperSoft helical coils specifically designed for the treatment of small aneurysms.Study Population: 300 participants who have been diagnosed with small ( 4.9 mm) intracranial aneurysms and who were treated with the coils from 16 centers. Study Methodology:Endovascular coiling of the aneurysm is performed per each institutions standard procedure.Data from each participant will be collected up to 12 months post procedure. There are up to five data points which include baseline (pre- procedure), procedure/post procedure through discharge and follow-up at 6 or 12 months. Data from imaging (2-D DSA, diagnostic) of aneurysm, clinical assessment (mRS, Hunt & Hess,NIHSS), aneurysm occlusion grading (Raymond-Roy grading scale /RRGS), retreatment and adverse events/safety will be collected per protocol at various time points. Study Endpoints or Outcomes:Efficacy: Raymond-Roy grading scale (RRGS) of 2 or better occlusion on follow-up angiography performed >150 days post embolization, not requiring retreatment.Safety: Freedom from new post-procedural bleeding and ischemic stroke associated with a 4-point worsening neurologically within 48 hours of aneurysm treatment or any new aneurysmal bleeding secondary to treated aneurysm. Follow up:All Study subjects will undergo follow-up angiographic (DSA or MRA) evaluations at 6 months and/or 12 months following the procedure or if an unscheduled visit is required.Statistics and Plans for Analysis:Two-sided 95% confidence intervals will be calculated about the estimated post EVT occlusion rates using the exact binomial distribution. Secondary analyses will include any neurological and mortality, bleeding rate of target aneurysms at one year (includes rebleeding of target ruptured aneurysms), recurrence rate/recanalization (at time of >150 day angiographic follow up), and retreatment rate (at one year). All clinical outcome analyses will be performed on the per protocol and ITT populations.
Recruiting | Aneurysm | Not Multisite
William Mack
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