N/A
N=120
The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
Wide-neck, Saccular Intracranial Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT01636453 ↗Enrolled (actual)
120
Serious AEs
30.4%
Results posted
Aug 2018
Primary outcome: Primary: Number of Participants With Raymond Class I Complete Obliteration at 12 Months — 98 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stent assisted coiling with the Liberty Stent (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Penumbra Inc.
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Raymond Class I Complete Obliteration at 12 Months |
98 | — |
| PRIMARY Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment. |
3 | — |
| SECONDARY Number of Ipsilateral Ischemic Strokes |
8 | — |
| SECONDARY Number of Participants With Device-related Serious Adverse Events |
17 | — |
| SECONDARY Number of Device Deployment Failures |
5 | — |
| SECONDARY Number of Device Migrations |
— | — |
| SECONDARY Number of Participants With Aneurysm Raymond Class I Occlusion Grading |
99 | — |
| SECONDARY Number of Intracranial Hemorrhages |
2 | — |
| SECONDARY Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2 |
106 | — |
| SECONDARY All Cause Mortality (Number of Deaths From Any Cause) |
— | — |
| SECONDARY Number of Retreatments |
4 | — |
| SECONDARY Number of Participants Who Experienced Device Patency |
2 | — |
| SECONDARY Number of Participants Who Experienced Aneurysm Recanalization |
6 | — |
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.
Eligibility Criteria
Inclusion Criteria
- At least 18 years old
- A wide-neck intracranial saccular aneurysm with a neck ≥ 4mm or a dome to neck ratio 12 months
- Signed Informed Consent
Exclusion Criteria
- Females who are pregnant or intend to become pregnant during the study. (Females of child-bearing potential must have a urinary pregnancy test within 7 days of enrollment)
- Extradural aneurysms
- Known multiple untreated cerebral aneurysms at study entry
- Recent history of subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment
- Admission platelet 3.0
- Contraindication to angiography such as elevated creatinine or known allergy to angiographic contrast
- Contraindication to CT and/or MRI scans
- Known allergy to the metal component of the Penumbra Liberty Stent System
- Evidence of active infection (WBC >10x109 /L)
- Any medical conditions that will not allow the necessary follow-up for this study (e.g., pre-existing neurological or psychiatric diseases)
- Current substance-abuse /illicit drug use
- Angiographic evidence of an arterial stenosis proximal to the target lesion that could prevent device deployment
- Contraindications to study medications (heparin, aspirin, clopidogrel, and radiographic contrasts)
Data sourced from ClinicalTrials.gov (NCT01636453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.