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

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 Overview

• Status: Withdrawn
• Conditions: Wide Neck Intracranial Aneurysms
• Intervention / Treatment: Device: Liberty Stent

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment by the Liberty Stent	Device: Liberty Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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).	6 months post-procedure
Procedural device-related serious adverse events	During the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Device patency and migration	At 6 months post-procedure
Intracranial hemorrhage	At 6 months post-procedure
Functional outcome as defined by the modified Rankin Scale (mRS)	At 6 months post-procedure
All cause mortality	At 6 months post-procedure
Retreatment	At 6 months

Collaborators and Investigators

• Sponsor: Penumbra Inc.
• Investigators: Principal Investigator: Werner Weber, PD Dr. med, Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): June 1, 2017

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 17, 2012
• First Posted (Estimate): December 20, 2012

Study Record Updates

• Last Update Posted (Actual): April 12, 2019
• Last Update Submitted That Met QC Criteria: April 10, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Arterial Diseases; Aneurysm; Intracranial Aneurysm
• Other Study ID Numbers: CLP 4928 (Other Identifier: Penumbra Inc)