Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed NA study, sponsored by Medical University of South Carolina.
NCT02259504 is a NA study that has completed, run by Medical University of South Carolina. The registered enrollment target is 299 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
To measure imaging outcomes of small (≤ 4.9 mm) intracranial aneurysms utilizing the HyperSoft® 3D (and HydroSoft® 3D, when commercially available) and HyperSoft® helical coils specifically designed for the treatment of small aneurysms.
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 |
What the finished NCT02259504 record still lists
NCT02259504 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (79% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02259504's enrollment target sits among peer trials
299 371st of 2000 higher than 1,630 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00353483 · 300 participants
Effect of Neoadjuvant or Adjuvant Systemic Therapy on Breast Cancers, Bone Marrow Cancer Cells, and Circulating Cancer Cells
- NCT00588185 · 300 participants · NA
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone Pet Imaging in Patients With Progressive Prostate Cancer
- NCT00682032 · 300 participants · NA
The Effect of Beta-glucan in Non-Small Cell Lung Cancer
- NCT00870064 · 300 participants · NA
The Treatment of Type I Open Fractures in Pediatrics
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia