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

NCT01636453 | Completed Results DMC

• 1 other identifier: CLP 5038 (IDE # G120050)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Wide-neck, Saccular Intracranial Aneurysms

Keywords

wide-neck; saccular; intracranial aneurysms; ICA; Stent assisted coiling; Liberty Stent

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Raymond Class I Complete Obliteration at 12 Months

  Complete aneurysmal obliteration is defined by the method of Raymond et al. (Class I) (Stroke 2001;32:1998-2004).

  At 12 months post-implant

• Number of Neurological Deaths or Major Ipsilateral Strokes at 12 Months Post Treatment.

  At 12 months post-implant

Secondary Outcomes (11)

• Number of Ipsilateral Ischemic Strokes

  At 12 months post-implant

• Number of Participants With Device-related Serious Adverse Events

  During the procedure

• Number of Device Deployment Failures

  During the procedure

• Number of Device Migrations

  12 months post-implant

• Number of Participants With Aneurysm Raymond Class I Occlusion Grading

  At 12 months post-implant

Study Arms (1)

Liberty Stent arm

EXPERIMENTAL

Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months

Device: Stent assisted coiling with the Liberty Stent

Interventions

Stent assisted coiling with the Liberty Stent DEVICE

Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months

Liberty Stent arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (3)

Swedish Medical Center

Denver, Colorado, 80112, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Stony Brook University Medical Center

Stony Brook, New York, 11794-8122, United States

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Michaella Corso
• Organization: Penumbra, Inc.

(510) 748-3200

Study Officials

• Demtrius Lopes, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

• Henry Woo, MD

  Stony Brook University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2012
• First Posted: July 10, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 23, 2018
• Results First Posted: August 23, 2018

Record last verified: 2018-04

Locations

US (3)