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

NCT ID: NCT01753388

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2017-06-30

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.

Conditions

Wide Neck Intracranial Aneurysms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment by the Liberty Stent

Group Type: EXPERIMENTAL

Liberty Stent

Intervention Type: DEVICE

Interventions

Liberty Stent

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Penumbra Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Werner Weber, PD Dr. med

Role: PRINCIPAL_INVESTIGATOR

Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

Locations

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

Countries

Germany

Other Identifiers

CLP 4928

Identifier Type: OTHER

Identifier Source: secondary_id

CLP 4928

Identifier Type: -

Identifier Source: org_study_id