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Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating Stent assisted coiling with the Liberty Stent for the treatment of Wide-neck, Saccular Intracranial Aneurysms

Research Study Title

The Penumbra Liberty Trial: Safety and Effectiveness in the Treatment of Wide-Neck Intracranial Aneurysms

Purpose

To assess the safety and effectiveness of the Penumbra Liberty Stent System as adjunctive treatment to embolic coils for wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA). The Liberty Stent System is an implantable device comprised of a stent and delivery system designed as an adjunct to embolic coils in the treatment of wide-neck, saccular, intracranial aneurysms. It has three components: an implant, an introducer sheath and a delivery wire assembly. The implant component is made of superelastic and biocompatible nitinol tubular material. Patients presenting with wide-neck, saccular, intracranial aneurysms in the internal carotid artery (ICA) from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments) will receive stent assisted coiling by the Penumbra Liberty Stent with any approved embolic coils currently on the market. Wide-neck aneurysms are defined by a neck ≥4mm or a dome-to-neck ratio <2. Each patient will be followed and assessed for 2, 6 and 12 months after enrollment.

To Learn more
Phase

3

Gender

Both Male and Female

Age

18 and up

Overall Status

Recruiting

Lead Sponsor

Penumbra Inc.

Duration

36 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 18 Years and up

Inclusion Criteria:

  • At least 18 years old

  • A wide-neck intracranial saccular aneurysm with a neck ≥ 4mm or a dome to neck ratio < 2 in the ICA from the cavernous segment to the carotid terminus (including the paraclinoid, ophthalmic, hypophyseal and posterior communicating segments)

  • Life expectancy > 12 months

  • Signed Informed Consent

Exclusion Criteria:

  • Females who are 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)

  • Extradural aneurysms

  • Known multiple untreated cerebral aneurysms at study entry

  • Recent history of subarachnoid hemorrhage, intracranial hemorrhage, or major surgery within one month of enrollment

  • Admission platelet < 50,000 or any known hemorrhagic diathesis, coagulation deficiency, or on oral anticoagulant therapy with an INR > 3.0

  • 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)

Site Locations (1)

Country State City Zip Facility and Contact
United States Illinois Chicago 60612 Rush University Medical Center
Demetrius Lopes, MD
312-563-3394
brainaneurysm@me.com

Demetrius Lopes, MD
Principal Investigator

Contact

Leticia Barraza, BS
510-748-3200 ext. 267

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01636453

Date Last Changed: February 4, 2014

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