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NCT02259504 · ClinicalTrials.gov registry record · NA
COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils
A NA study, sponsored by Medical University of South Carolina.
- Completed
- Registry status
- NA
- Development phase
- 299
- Enrollment target
NCT02259504 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 299 participants.
The verdict
NCT02259504, a NA study, has completed, sponsored by Medical University of South Carolina.
- COMPLETED
- Registry status
- NA
- Development phase
- 299 participants
- Enrollment target
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.
Interventions
- OTHER PHASE 1- HyperSoft® 3D and HyperSoft® Helical Coils
- OTHER PHASE 2 - HydroSoft® 3D and HydroSoft® Helical Coils
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2014-07 |
| Est. Completion | 2021-01-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02259504
The ClinicalTrials.gov registry entry for NCT02259504 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 755 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PHASE 1- HyperSoft® 3D and HyperSoft® Helical Coils is the first listed.
NCT02259504 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02259504 about?
NCT02259504 is a clinical study titled "COAST: Coiling of Aneurysms Smaller Than 5mm With Hypersoft® and Hydrogel Coils". 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, wi...
What is the current status of trial NCT02259504?
This trial is currently completed. It is a NA study. The enrollment target is 299 participants. The study started on 2014-07. Estimated completion is 2021-01-25.
What interventions are being tested in trial NCT02259504?
The interventions under investigation include: PHASE 1- HyperSoft® 3D and HyperSoft® Helical Coils (OTHER), PHASE 2 - HydroSoft® 3D and HydroSoft® Helical Coils (OTHER).
Who is sponsoring clinical trial NCT02259504?
This trial is sponsored by Medical University of South Carolina, which has 755 total clinical trials registered on ClinicalTrials.gov.
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