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COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils

NCT02259504 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2021-02-25

No results posted yet for this study

Summary

This is a prospective, single-arm, multi-center post-marketing Study. The Study will commence as a single phase, with an optional second phase to follow at the discretion of the sponsor. Up to 300 eligible Subjects with small (\< 4.9 mm) intracranial aneurysms, who consent to Study participation, will be treated in Phase 1 with MicroVention HyperSoft® 3D and HyperSoft® Helical coils with or without balloon remodeling or stent assistance at the discretion of the treating physician. The operator, at his/her discretion, may choose to frame the aneurysm with HyperSoft® 3D or any other bare metal coil but must finish the remainder of the aneurysm with HyperSoft® 3D and/or HyperSoft® Helical coils. At the discretion of the sponsor, additional patients, up to 300 patients total for the overall Study, with eligible aneurysms will be enrolled into Phase 2. In Phase 2, the aneurysm must be framed with a HydroFrame® or HydroSoft® 3D coil and filled/finished primarily with hydrogel coils. The intent to treat is to frame, fill and finish with all hydrogel coils. However, at the discretion of the treating physician, a bare platinum coil may be used to fill or finish, as long as a minimum of 50% (in total coil length) of hydrogel coils are used. Data will be collected on immediate and post-treatment angiographic occlusion rates (RRGS), new peri-procedural imaging-confirmed hemorrhage or ischemic stroke, neurological morbidity and mortality rates, recurrence rates, bleeding rates, retreatment rates, serious adverse events, \>150 day angiographic occlusion rates (RRGS) and occlusion status. This will serve to establish the acute and sustained efficacy of EVT of small intracranial aneurysms with the specified microcoils, aided by balloon and/or stent remodeling where appropriate.

Conditions

  • Small Intracranial Aneurysms

Interventions

OTHER

PHASE 1- HyperSoft® 3D and HyperSoft® Helical Coils

Framing with HyperSoft® 3D or any FDA-approved bare platinum coil. Must fill and finish the the aneurysm with HyperSoft® 3D and/or HyperSoft® helical coils.

OTHER

PHASE 2 - HydroSoft® 3D and HydroSoft® Helical Coils

Framing with HydroFrame® or HydroSoft® 3D coils. Must fill the aneurysm with HydroFrame®, HydroSoft® (3D and/or Helical), and/or HydroFill® Coils and finish with HydroSoft® (3D and/or Helical) Coils.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Jonathan Lena, MD · Medical University of South Carolina

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2021-01-25
Completion
2021-01-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02259504 on ClinicalTrials.gov