Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
This study is currently recruiting participants.
Verified December 2012 by Penumbra Inc.
Sponsor:
Penumbra Inc.
Information provided by (Responsible Party):
Penumbra Inc.
ClinicalTrials.gov Identifier:
NCT01753388
First received: December 17, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Wide Neck Intracranial Aneurysms |
Device: Liberty Stent |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms |
Resource links provided by NLM:
Further study details as provided by Penumbra Inc.:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Procedural device-related serious adverse events [ Time Frame: During the procedure ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Device patency and migration [ Time Frame: At 6 months post-procedure ] [ Designated as safety issue: Yes ]
- Intracranial hemorrhage [ Time Frame: At 6 months post-procedure ] [ Designated as safety issue: Yes ]
- Functional outcome as defined by the modified Rankin Scale (mRS) [ Time Frame: At 6 months post-procedure ] [ Designated as safety issue: Yes ]
- All cause mortality [ Time Frame: At 6 months post-procedure ] [ Designated as safety issue: Yes ]
- Retreatment [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Treatment by the Liberty Stent | Device: Liberty Stent |
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01753388
Contacts
| Contact: Olivier Salem, PhD | 33 6 82 33 05 06 | osellam@penumbrainc.com |
| Contact: Siu Po Sit, PhD | 510 748 3200 ext 221 | siupo.sit@penumbrainc.com |
Locations
| Germany | |
| Asklepios Klinik Altona | Recruiting |
| Hamburg, Germany | |
| Contact: Prof. Dr. med. Bernd Eckert | |
| Principal Investigator: Prof. Dr. med. Bernd Eckert | |
| Universitätsklinikum des Saarlandes | Recruiting |
| Homburg/Saar, Germany | |
| Contact: Prof. Dr. med. Wolfgang Reith | |
| Principal Investigator: Prof. Dr. med. Wolfgang Reith | |
| Universitätsklinikum Magdeburg A. ö. R. | Recruiting |
| Magdeburg, Germany | |
| Contact: Prof. Dr. med. Martin Skalej | |
| Principal Investigator: Prof. Dr. med. Martin Skalej | |
| Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen | Recruiting |
| Recklinghausen, Germany | |
| Contact: PD Dr. med. Werner Weber | |
| Principal Investigator: PD Dr. med Werner Weber | |
Sponsors and Collaborators
Penumbra Inc.
Investigators
| Principal Investigator: | Werner Weber, PD Dr. med | Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen |
More Information
No publications provided
| Responsible Party: | Penumbra Inc. |
| ClinicalTrials.gov Identifier: | NCT01753388 History of Changes |
| Other Study ID Numbers: | CLP 4928, CLP 4928 |
| Study First Received: | December 17, 2012 |
| Last Updated: | December 17, 2012 |
| Health Authority: | Germany:Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM) |
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 16, 2013