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COAST: COILING OF ANEURYSMS SMALLER THAN 5 MM WITH HYPERSOFT

Description

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.

Phase

N/A

Inclusion and Exclusion Criteria

  • Inclusion Criteria Candidates for this Study must meet all of the following criteria to be enrolled in the Study:
  • Subject age ≥ 18 and ≤ 80 with a diagnosis of ruptured or unruptured saccular intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion
  • Aneurysm size [largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen, and including any thrombosed portions] ≤ 4.9 mm
  • If ruptured aneurysm: Hunt and Hess 0-3
  • If unruptured aneurysm: Subject grade Modified Rankin Scale mRS 0 - 2
  • The investigator believes the aneurysm is appropriate for the designated Phase coiling paradigm. (Phase 1: Frame, fill and finish with Microvention HyperSoft® 3D and/or HyperSoft® helical coils. The operator at his discretion may frame with any bare metal framing coil but the remainder of the coils must be HyperSoft® 3D or HyperSoft® helical coils. Phase 2: The aneurysm must be framed with HydroSoft® 3D and filled/finished with HyperSoft® 3D and/or HyperSoft® helical coils.)
  • Signed informed consent. 3.4.3 Exclusion Criteria Candidates will be ineligible for enrollment in the Study if any of the following conditions apply:
  • Patient has more than one aneurysm requiring treatment in the current treatment session, and only one of those to be treated aneurysms fits the current Study inclusion criteria (i.e. if either (1) a patient has multiple aneurysms, but only one will be treated at enrollment; or (2) if two or more aneurysms are treated during the current treatment session and BOTH are able to be enrolled, then they remain eligible for the Study). Non-treated additional aneurysms may be treated after 30 days from the incident procedure with any coil type that the operator chooses, and, if eligible, those aneurysms may also be enrolled as an additional enrollment.
  • Prior treatment (surgical or endovascular) of the target aneurysm
  • Subject with social, medical, or psychological conditions that interfere with treatment and follow-up evaluation
  • Women who are pregnant or plan to become pregnant during the Study
  • Use of other modified coils (Matrix, HydroCoil® or fibered coils) - except Phase 2 as noted above in the inclusion criteria
  • Use (current or prior) of liquid embolic material in the treatment of the target aneurysm
  • Life expectancy less than 12 months
  • Presence of arteriovenous malformation or fistula
  • Presence of fusiform, mycotic, traumatic, dissecting or tumoral aneurysms in any location
  • Intended or planned aneurysm treatment by parent vessel occlusion

Sites

Please contact Sandy Leong to learn more about where you can participate in this trial. Please use the contact form on the right side.

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