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

Completed · Not applicable

Conditions studied: Small Intracranial Aneurysms

In brief

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.

Key facts

Study ID

NCT02259504

Run by

Medical University of South Carolina

People needed

299

Starts

2014-07-01

Expected to finish

2021-01-25

Last updated by the study team

2021-02-25

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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: Frame with MicroVention HydroFrame® or HydroSoft® 3D coils and fill/finish with sufficient hydrogel coils to ensure 50% hydrogel by length. 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.
• Signed informed consent.

You may not qualify if…

• 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 10. Intended or planned aneurysm treatment by parent vessel occlusion

Where it is running

• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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