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NCT05636124 · ClinicalTrials.gov registry record · NA
Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms
A NA study of Intracranial Aneurysms and Wide Neck Intracranial Aneurysms, sponsored by Icahn School of Medicine at Mount Sinai.
- Active
- Registry status
- NA
- Development phase
- 50
- Enrollment target
- 5
- Study locations
NCT05636124: Active NA study of Intracranial Aneurysms and Wide Neck Intracranial Aneurysms, sponsored by Icahn School of Medicine at Mount Sinai.
NCT05636124 is a NA study of Intracranial Aneurysms and Wide Neck Intracranial Aneurysms that is active but no longer recruiting, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 50 participants, above the 38-participant average among 4 other Intracranial Aneurysms trials with a reported enrollment target (32% higher). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05636124, a NA study of Intracranial Aneurysms and Wide Neck Intracranial Aneurysms, is active but no longer recruiting, sponsored by Icahn School of Medicine at Mount Sinai.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
- 5
- Study locations
Study Summary
This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.
Primary Outcome
Modified Raymond Roy 1-2 occlusion at 18 months without retreatment. The Raymond-Roy Occlusion Classification has 3 responses, where Grade 1 is complete occlusion, no flow of contrast seen in the sac, Grade 2 is partial occlusion, some flow in the neck or sac, and Grade 3 is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.
Conditions Studied
Interventions
- DEVICE Kaneka i-ED coil
Study Locations (5)
Florida
- Baptist Health Jacksonville - Jacksonville
- University of South Florida - Tampa
California
- Sutter Health - Danville
New York
- Icahn School of Medicine at Mount Sinai - New York
South Carolina
- Prisma Health - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2023-06-02 |
| Est. Completion | 2027-07 |
| Phase | NA |
What the registry record for NCT05636124 still lists
NCT05636124 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, above the 38-participant average among 4 other Intracranial Aneurysms trials with a reported enrollment target (32% higher).
The record links to 2 conditions, with Intracranial Aneurysms appearing as the primary indexed condition, and to 1 intervention - of which Kaneka i-ED coil is the first listed.
NCT05636124 lists 5 locations in 4 states (Florida, California, New York).
Frequently Asked Questions
What is clinical trial NCT05636124 about?
NCT05636124 is a clinical study titled "Kaneka iED Coil System for the Treatment of Wide Necked Ruptured and Unruptured Intracranial Aneurysms". This is a multi-center, prospective, propensity matched twin armed study conducted on 50 patients in the experimental arm followed for 18 months after intervention evaluating cost effectiveness, safety and efficacy of therapy.
What is the current status of trial NCT05636124?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 50 participants. The study started on 2023-06-02. Estimated completion is 2027-07.
What conditions does trial NCT05636124 study?
This clinical trial studies the following conditions: Intracranial Aneurysms, Wide Neck Intracranial Aneurysms.
What interventions are being tested in trial NCT05636124?
The interventions under investigation include: Kaneka i-ED coil (DEVICE).
Who is sponsoring clinical trial NCT05636124?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05636124 being conducted?
This trial has 5 study locations across California, Florida, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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