Wide Neck Intracranial AneurysmsPhase 2NCT01753388
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
A Phase 2 study testing Liberty Stent in people with Wide Neck Intracranial Aneurysms, run by Penumbra Inc. at 4 sites in Germany.
Trial summary
The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wide Neck Intracranial Aneurysms
- What is being tested?
- Liberty Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesGermany
- Study dates
- Dec 2012to Jun 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient from 18 to 85 years old
- A symptomatic unruptured saccular intracranial aneurysm with a neck ≥4mm (or a dome to neck ratio <2) and a parent vessel diameter between 2.5 to 5.0 mm (inclusive) in both the anterior and posterior circulation of the brain, that is amenable to stent-assisted coiling. "Symptomatic" is defined as any neurological symptoms attributed to the target aneurysm.
- Life expectancy >6 months
- Signed Informed Consent
Who cannot join
- Aneurysm with branches from the aneurysm base
- Rapidly growing aneurysm
- Daughter aneurysm
- Aneurysm with partial or complex calcifications
- Females who are nursing, 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 and use an approved highly efficient contraceptive method during the study
- Multiple untreated cerebral aneurysms at study entry
Show all 19Show fewer
- Recent history of stroke, TIA, subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment
- Previous brain surgery or irradiation of the target treatment territory that would, in the opinion of the investigator, interfere with the treatment of the target aneurysm
- Admission platelet <150,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy
- Underlying unstable Coronary Artery Disease, cardiac insufficiency or Myocardial Infarction
- 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)
- Patients unable to sign Informed Consent due to the emergency conditions of the intervention
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Asklepios Klinik Altona
Hamburg
Universitätsklinikum des Saarlandes
Homburg/Saar
Universitätsklinikum Magdeburg A. ö. R.
Magdeburg
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
Recklinghausen
About this study
The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.
- Conditions
- Wide Neck Intracranial Aneurysms
- Being tested
- Liberty Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberty StentDevice
| Study group | Role | What they receive |
|---|---|---|
| Treatment by the Liberty Stent | Experimental | Not described Receives: Device: Liberty Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aneurysmal occlusion of the treated target lesion on 6-month angiography as defined by the method of Roy et al. (Stroke 2001;32:1998-2004).
Measured: 6 months post-procedure
Procedural device-related serious adverse events
Measured: During the procedure
Secondary outcomes (5)
Device patency and migration
Measured: At 6 months post-procedure
Intracranial hemorrhage
Measured: At 6 months post-procedure
Functional outcome as defined by the modified Rankin Scale (mRS)
Measured: At 6 months post-procedure
All cause mortality
Measured: At 6 months post-procedure
Retreatment
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Why it stopped: The study was never initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wide Neck 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penumbra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Werner Weber, PD Dr. med, Principal investigator, Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01753388
- Sponsor's protocol ID
- CLP 4928
- Other IDs
- CLP 4928
- Status last verified
- Apr 2019
- First submitted
- 17 Dec 2012
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT01753388
- Acronym / sponsor ID
- CLP 4928
- Conditions
- Wide Neck Intracranial Aneurysms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Penumbra Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 20 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and performance of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment by the Liberty Stent | Experimental | Device: Liberty Stent |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient from 18 to 85 years old
- A symptomatic unruptured saccular intracranial aneurysm with a neck ≥4mm (or a dome to neck ratio <2) and a parent vessel diameter between 2.5 to 5.0 mm (inclusive) in both the anterior and posterior circulation of the brain, that is amenable to stent-assisted coiling. "Symptomatic" is defined as any neurological symptoms attributed to the target aneurysm.
- Life expectancy >6 months
- Signed Informed Consent
Key exclusion criteria (19 listed)
- Aneurysm with branches from the aneurysm base
- Rapidly growing aneurysm
- Daughter aneurysm
- Aneurysm with partial or complex calcifications
- Females who are nursing, 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 and use an approved highly efficient contraceptive method during the study
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 |
|---|---|---|
| Liberty Stent | Device | Treatment by the Liberty Stent |
Primary outcome
Aneurysmal occlusion of the treated target lesion on 6-month angiography as defined by the method of Roy et al. (Stroke 2001;32:1998-2004).
Time frame: 6 months post-procedure
Procedural device-related serious adverse events
Time frame: During the procedure
5 secondary outcomes
Device patency and migration
Time frame: At 6 months post-procedure
Intracranial hemorrhage
Time frame: At 6 months post-procedure
Functional outcome as defined by the modified Rankin Scale (mRS)
Time frame: At 6 months post-procedure
All cause mortality
Time frame: At 6 months post-procedure
Retreatment
Time frame: At 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
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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.
Werner Weber, PD Dr. med principal investigator
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Liberty Stent in people with Wide Neck Intracranial Aneurysms, run by Penumbra Inc. at 4 sites in Germany.
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 19 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: withdrawn, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Aneurysmal occlusion of the treated target lesion on 6-month angiography as defined by the method of Roy et al. (Stroke 2001;32:1998-2004). (time frame: 6 months post-procedure). 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 12 Apr 2019.