Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01636453 · ClinicalTrials.gov registry record · NA
The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
A NA study, sponsored by Penumbra.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT01636453 is a NA study that has completed, run by Penumbra. The registered enrollment target is 120 participants.
The verdict
NCT01636453, a NA study, has completed, sponsored by Penumbra.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
Study Summary
To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a dome-to-neck ratio \<2. Each patient will be followed and assessed for 2, 6 and 12 months after enrollment.
Interventions
- DEVICE Stent assisted coiling with the Liberty Stent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2012-09 |
| Est. Completion | 2016-12 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01636453
The ClinicalTrials.gov registry entry for NCT01636453 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Penumbra, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Stent assisted coiling with the Liberty Stent is the first listed.
NCT01636453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01636453 about?
NCT01636453 is a clinical study titled "The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms". To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system design...
What is the current status of trial NCT01636453?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2012-09. Estimated completion is 2016-12.
What interventions are being tested in trial NCT01636453?
The interventions under investigation include: Stent assisted coiling with the Liberty Stent (DEVICE).
Who is sponsoring clinical trial NCT01636453?
This trial is sponsored by Penumbra, which has 25 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.