Clinical trial NCT01753388: Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
Official title: Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Wide Neck Intracranial Aneurysms
Lead sponsor: Penumbra Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
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).
timeFrame: 6 months post-procedure
measure: Procedural device-related serious adverse events
timeFrame: During the procedure
Secondary outcomes:
measure: Device patency and migration
timeFrame: At 6 months post-procedure
measure: Intracranial hemorrhage
timeFrame: At 6 months post-procedure
measure: Functional outcome as defined by the modified Rankin Scale (mRS)
timeFrame: At 6 months post-procedure
measure: All cause mortality
timeFrame: At 6 months post-procedure
measure: Retreatment
timeFrame: At 6 months
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona
city: Homburg/Saar
country: Germany
facility: Universitätsklinikum des Saarlandes
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg A. ö. R.
city: Recklinghausen
country: Germany
facility: Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
Study officials:
affiliation: Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
name: Werner Weber, PD Dr. med
role: PRINCIPAL_INVESTIGATOR
References: