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

Penumbra

Status and phase

Withdrawn

Phase 2

Conditions

Wide Neck Intracranial Aneurysms

Treatments

Device: Liberty Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT01753388

CLP 4928 (Other Identifier)

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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