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

NCT01753388 | Withdrawn Phase 2 DMC

• 1 other identifier: CLP 4928
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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

Study Arms (1)

Treatment by the Liberty Stent

EXPERIMENTAL

Device: Liberty Stent

Interventions

Liberty Stent DEVICE

Treatment by the Liberty Stent

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Penumbra Inc.: lead

Study Sites (4)

Asklepios Klinik Altona

Hamburg, Germany

Location

Universitätsklinikum des Saarlandes

Homburg/Saar, Germany

Location

Universitätsklinikum Magdeburg A. ö. R.

Magdeburg, Germany

Location

Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

Recklinghausen, Germany

Location

Study Officials

• Werner Weber, PD Dr. med

  Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 20, 2012
• Study Start: December 1, 2012
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

DE (4)