The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
This study is currently recruiting participants.
Verified May 2013 by Penumbra Inc.
Sponsor:
Penumbra Inc.
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01636453
First received: July 2, 2012
Last updated: May 17, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Wide-neck, Saccular Intracranial Aneurysms |
Device: Stent assisted coiling with the Liberty Stent |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms |
Resource links provided by NLM:
Further study details as provided by Penumbra Inc.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Complete aneurysmal occlusion is defined by the method of Roy et al. (Class 1) (Stroke 2001;32:1998-2004).
- Neurological death or major ipsilateral stroke at 12 months post treatment. [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- All ipsilateral ischemic strokes [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]Defined as episodes of focal or global neurological dysfunction due to brain or retinal infarction in the same hemisphere of the target aneurysm with signs and symptoms that persist for 24 hours or longer. When appropriate, non contrast CT scans will be used to eliminate hemorrhagic strokes
- Device-related serious adverse events [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]The number of participants with device-related Serious Adverse Events as a measure of safety of the procedure and device. The FDA definitions for Serious Adverse Events are used.
- Device deployment failure [ Time Frame: During the procedure ] [ Designated as safety issue: No ]Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm
- Device migration [ Time Frame: 12 months post-implant ] [ Designated as safety issue: Yes ]Migration is defined as movement of the Liberty stent by more than 5 mm as documented by the 12 month angiogram when compared to its immediate post-implant position.
- Aneurysm occlusion [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: No ]
- Intracranial hemorrhages [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]Inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages (symptomatic or asymptomatic). Symptomatic is defined as a 4 point or more increase in the NIHSS from baseline.
- Functional outcome as defined by the modified Rankin Scale (mRS) [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]
- All cause mortality [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: Yes ]
- Retreatment [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: No ]Defined as any intervention after the completion of the initial stent assisted coiling procedure
- Device patency [ Time Frame: at 12 months post-implant ] [ Designated as safety issue: No ]Patency will be defined by the WASID method.
- Aneurysm recanalization [ Time Frame: At 12 months post-implant ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 120 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Liberty Stent arm
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
|
Device: 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
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636453
Contacts
| Contact: Leticia Barraza, BS | 510-748-3200 ext 267 | leticia.barraza@penumbrainc.com |
| Contact: Siu Po Sit, PhD | 5107483200 ext 221 | siupo.sit@penumbrainc.com |
Locations
| United States, Colorado | |
| Swedish Medical Center | Not yet recruiting |
| Denver, Colorado, United States, 80112 | |
| Contact: David Loy, MD 314-709-2561 David.Loy@riaco.com | |
| Contact: Gwendolyn Dooley, FNP 303-726-9215 Gwendolyn.dooley@riaco.com | |
| Principal Investigator: David Loy, MD | |
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Demetrius Lopes, MD 312-563-3394 brainaneurysm@me.com | |
| Contact: Christy Anton (312) 942-1489 Christy_Anton@rush.edu | |
| Principal Investigator: Demetrius Lopes, MD | |
| United States, New York | |
| Stony Brook University Medical Center | Not yet recruiting |
| Stony Brook, New York, United States, 11794-8122 | |
| Contact: Henry Woo, MD 631-444-1610 Henry.Woo@sbumed.org | |
| Principal Investigator: Henry Woo, MD | |
Sponsors and Collaborators
Penumbra Inc.
Investigators
| Principal Investigator: | Demtrius Lopes, MD | Rush University Medical Center |
| Principal Investigator: | Henry Woo, MD | Stony Brook University Medical Center |
More Information
No publications provided
| Responsible Party: | Penumbra Inc. |
| ClinicalTrials.gov Identifier: | NCT01636453 History of Changes |
| Other Study ID Numbers: | CLP 5038 (IDE # G120050) |
| Study First Received: | July 2, 2012 |
| Last Updated: | May 17, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Penumbra Inc.:
|
wide-neck saccular intracranial aneurysms |
ICA Stent assisted coiling Liberty Stent |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013