Wide-neck, Saccular Intracranial AneurysmsNCT01636453
The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
A study testing Stent assisted coiling with the Liberty Stent in people with Wide-neck, Saccular Intracranial Aneurysms, run by Penumbra Inc. at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wide-neck, Saccular Intracranial Aneurysms
- What is being tested?
- Stent assisted coiling with the Liberty Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2012to Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Rush University Medical Center
Chicago, Illinois, 60612
Swedish Medical Center
Denver, Colorado, 80112
Stony Brook University Medical Center
Stony Brook, New York, 11794-8122
About this study
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.
- Being tested
- Stent assisted coiling with the Liberty Stent
- Keywords
- wide-neck, saccular, intracranial aneurysms, ICA, Stent assisted coiling, Liberty Stent
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent assisted coiling with the Liberty StentDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Liberty Stent 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 Receives: Device: Stent assisted coiling with the Liberty Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 12 months post-implant
Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.
Measured: At 12 months post-implant
Secondary outcomes (11)
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
Measured: At 12 months post-implant
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.
Measured: During the procedure
Number of Device Deployment Failures
Defined by the failure of the device to deploy or failure to correctly position the device over the aneurysm
Measured: During the procedure
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.
Measured: 12 months post-implant
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.
Measured: At 12 months post-implant
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.
Measured: At 12 months post-implant
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.
Measured: At 12 months post-implant
All Cause Mortality (Number of Deaths From Any Cause)
Measured: At 12 months post-implant
Number of Retreatments
Defined as any intervention after the completion of the initial stent assisted coiling procedure
Measured: At 12 months post-implant
Number of Participants Who Experienced Device Patency
Device patency (stenosis) at 12 months
Measured: at 12 months post-implant
Number of Participants Who Experienced Aneurysm Recanalization
Measured: At 12 months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Wide-neck, Saccular Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Demtrius Lopes, MD, Principal investigator, Rush University Medical CenterHenry Woo, MD, Principal investigator, Stony Brook University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01636453
- Sponsor's protocol ID
- CLP 5038 (IDE # G120050)
- Status last verified
- Apr 2018
- First submitted
- 2 Jul 2012
- Last updated
- 23 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT01636453
- Acronym / sponsor ID
- CLP 5038 (IDE # G120050)
- Keywords
- wide-neck, saccular, intracranial aneurysms, ICA, Stent assisted coiling, Liberty Stent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 10 Jul 2012 (estimated)
- Results
- Posted 23 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liberty Stent arm | Experimental | Device: Stent assisted coiling with the Liberty StentPatients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent assisted coiling with the Liberty StentPatients 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 | Liberty Stent arm |
Primary outcome
Number of Participants With Raymond Class I Complete Obliteration at 12 Months
Time frame: At 12 months post-implant
Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).
Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.
Time frame: At 12 months post-implant
11 secondary outcomes
Number of Ipsilateral Ischemic Strokes
Time frame: At 12 months post-implant
Number of Participants With Device-related Serious Adverse Events
Time frame: During the procedure
Number of Device Deployment Failures
Time frame: During the procedure
Number of Device Migrations
Time frame: 12 months post-implant
Number of Participants With Aneurysm Raymond Class I Occlusion Grading
Time frame: At 12 months post-implant
Number of Intracranial Hemorrhages
Time frame: At 12 months post-implant
Number of Participants With Functional Outcome as Defined by the Modified Rankin Scale (mRS) 0-2
Time frame: At 12 months post-implant
All Cause Mortality (Number of Deaths From Any Cause)
Time frame: At 12 months post-implant
Number of Retreatments
Time frame: At 12 months post-implant
Number of Participants Who Experienced Device Patency
Time frame: at 12 months post-implant
Number of Participants Who Experienced Aneurysm Recanalization
Time frame: At 12 months post-implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demtrius Lopes, MD principal investigator
Rush University Medical Center
Henry Woo, MD principal investigator
Stony Brook University Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent assisted coiling with the Liberty Stent in people with Wide-neck, Saccular Intracranial Aneurysms, run by Penumbra Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Raymond Class I Complete Obliteration at 12 Months (time frame: At 12 months post-implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.