Wide-neck, Saccular Intracranial Aneurysms Clinical Trial
Official title:
The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
| Verified date | April 2018 |
| Source | Penumbra Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | December 2016 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | Swedish Medical Center | Denver | Colorado |
| United States | Stony Brook University Medical Center | Stony Brook | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Penumbra Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Raymond Class I Complete Obliteration at 12 Months | Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004). | At 12 months post-implant | |
| Primary | Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment. | At 12 months post-implant | ||
| Secondary | Number of Ipsilateral Ischemic Strokes | 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 | At 12 months post-implant | |
| Secondary | Number of Participants With Device-related Serious Adverse Events | 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. | During the procedure | |
| Secondary | Number of Device Deployment Failures | Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm | During the procedure | |
| Secondary | Number of Device Migrations | 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. | 12 months post-implant | |
| Secondary | Number of Participants With Aneurysm Raymond Class I Occlusion Grading | Raymond Class I Occlusion grading defined as complete obliteration of the aneurysm at 12 months. | At 12 months post-implant | |
| Secondary | Number of Intracranial Hemorrhages | Inclusive of subarachnoid, intraventricular or intraparenchymal hemorrhages (symptomatic or asymptomatic). Symptomatic is defined as a 4 point or more increase in the National Institutes of Health Stroke Scale (NIHSS) from baseline. The NIHSS ranges from 1 to 42, with higher scores indicating greater severity of stroke. | At 12 months post-implant | |
| Secondary | Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2 | The Modified Rankin Scale measures functional ability on a scale from 0-5, with 0 indicating no symptoms at all and 5 indicating severe disability. | At 12 months post-implant | |
| Secondary | All Cause Mortality (Number of Deaths From Any Cause) | At 12 months post-implant | ||
| Secondary | Number of Retreatments | Defined as any intervention after the completion of the initial stent assisted coiling procedure | At 12 months post-implant | |
| Secondary | Number of Participants Who Experienced Device Patency | Device patency (stenosis) at 12 months | at 12 months post-implant | |
| Secondary | Number of Participants Who Experienced Aneurysm Recanalization | At 12 months post-implant |