Overview

This trial is active, not recruiting.

Condition wide-neck, saccular intracranial aneurysms
Treatment stent assisted coiling with the liberty stent
Phase phase 3
Sponsor Penumbra Inc.
Start date September 2012
End date December 2017
Trial size 120 participants
Trial identifier NCT01636453, CLP 5038 (IDE # G120050)

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
stent assisted coiling with the liberty stent
Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months

Primary Outcomes

Measure
Complete aneurysmal occlusion of the treated target lesion on 12-month angiography in the absence of retreatment, parent artery stenosis (>50%), or target aneurysm rupture.
time frame: At 12 months post-implant
Neurological death or major ipsilateral stroke at 12 months post treatment.
time frame: At 12 months post-implant

Secondary Outcomes

Measure
All ipsilateral ischemic strokes
time frame: At 12 months post-implant
Device-related serious adverse events
time frame: During the procedure
Device deployment failure
time frame: During the procedure
Device migration
time frame: 12 months post-implant
Aneurysm occlusion
time frame: At 12 months post-implant
Intracranial hemorrhages
time frame: At 12 months post-implant
Functional outcome as defined by the modified Rankin Scale (mRS)
time frame: At 12 months post-implant
All cause mortality
time frame: At 12 months post-implant
Retreatment
time frame: At 12 months post-implant
Device patency
time frame: at 12 months post-implant
Aneurysm recanalization
time frame: At 12 months post-implant

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - At least 18 years old - A wide-neck intracranial saccular aneurysm with a neck ≥ 4mm or a dome to neck ratio <2 in the ICA from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) - Life expectancy > 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 <50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR >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)

Additional Information

Official title The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
Principal investigator Demtrius Lopes, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Penumbra Inc..