Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms - Full Text View

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:

MedlinePlus related topics: Aneurysms Brain Aneurysm

U.S. FDA Resources

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:	June 2017
Estimated Primary Completion Date:	June 2017 (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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01753388

Locations


Germany
Asklepios Klinik Altona
Hamburg, Germany
Universitätsklinikum des Saarlandes
Homburg/Saar, Germany
Universitätsklinikum Magdeburg A. ö. R.
Magdeburg, Germany
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
Recklinghausen, Germany

Sponsors and Collaborators

Penumbra Inc.

Investigators


Principal Investigator:	Werner Weber, PD Dr. med	Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

More Information


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:	September 26, 2016
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 September 28, 2016