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NCT06282939 · ClinicalTrials.gov registry record
Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry
A clinical trial of Intracranial Aneurysm, sponsored by HCA Healthcare Research Institute.
- Recruiting
- Registry status
- 600
- Enrollment target
- 1
- Study location
NCT06282939 is a study of Intracranial Aneurysm that is actively recruiting participants, run by HCA Healthcare Research Institute. The registered enrollment target is 600 participants, below the 9,153-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06282939, a study of Intracranial Aneurysm, is actively recruiting participants, sponsored by HCA Healthcare Research Institute.
- RECRUITING
- Registry status
- 600 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System. The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the OptiMAX Coils, in the real-world treatment of intracranial aneurysms. Imaging will be analyzed by a designated core neuroimaging lab to assess procedural success and aneurysm occlusion rates. Intent to treat population total: 700 patients 600 patients, up to 100 screen failures.
Conditions Studied
Interventions
- DEVICE OPTIMA and OPTIMAX Coils manufactured by Balt USA
Study Locations (1)
Texas
- Med City Plano - Plano
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2023-11-01 |
| Est. Completion | 2027-12-01 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06282939
The ClinicalTrials.gov registry entry for NCT06282939 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 600 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 9,153-participant average among 14 other Intracranial Aneurysm trials with a reported enrollment target (93% lower). The listed sponsor is HCA Healthcare Research Institute, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Intracranial Aneurysm appearing as the primary indexed condition, and to 1 intervention - of which OPTIMA and OPTIMAX Coils manufactured by Balt USA is the first listed.
NCT06282939 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT06282939 about?
NCT06282939 is a clinical study titled "Optima Coil Performance in The Interventional Management of Intracranial Aneurysms Registry". This is a prospective, open-label, consecutive enrollment, multi-center, U.S. registry of patients with intracranial aneurysms who are treated with the Optima Coil System. The primary objective of this registry is to evaluate the safety and effectiveness of the OptimaTM Coil System, including the O...
What is the current status of trial NCT06282939?
This trial is currently recruiting. The enrollment target is 600 participants. The study started on 2023-11-01. Estimated completion is 2027-12-01.
What conditions does trial NCT06282939 study?
This clinical trial studies the following conditions: Intracranial Aneurysm.
What interventions are being tested in trial NCT06282939?
The interventions under investigation include: OPTIMA and OPTIMAX Coils manufactured by Balt USA (DEVICE).
Who is sponsoring clinical trial NCT06282939?
This trial is sponsored by HCA Healthcare Research Institute, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06282939 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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