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

Primary Purpose

Wide Neck Intracranial Aneurysms

Status
Withdrawn
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Liberty Stent
Sponsored by
Penumbra Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wide Neck Intracranial Aneurysms

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Asklepios Klinik Altona
  • Universitätsklinikum des Saarlandes
  • Universitätsklinikum Magdeburg A. ö. R.
  • Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment by the Liberty Stent

Arm Description

Outcomes

Primary Outcome Measures

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).
Procedural device-related serious adverse events

Secondary Outcome Measures

Device patency and migration
Intracranial hemorrhage
Functional outcome as defined by the modified Rankin Scale (mRS)
All cause mortality
Retreatment

Full Information

First Posted
December 17, 2012
Last Updated
April 10, 2019
Sponsor
Penumbra Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01753388
Brief Title
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
Official Title
Safety and Performance of the Penumbra Liberty Stent in the Treatment of Wide-Neck, Saccular, Intracranial Aneurysms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Withdrawn
Why Stopped
The study was never initiated
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Penumbra Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wide Neck Intracranial Aneurysms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment by the Liberty Stent
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Liberty Stent
Primary Outcome Measure Information:
Title
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).
Time Frame
6 months post-procedure
Title
Procedural device-related serious adverse events
Time Frame
During the procedure
Secondary Outcome Measure Information:
Title
Device patency and migration
Time Frame
At 6 months post-procedure
Title
Intracranial hemorrhage
Time Frame
At 6 months post-procedure
Title
Functional outcome as defined by the modified Rankin Scale (mRS)
Time Frame
At 6 months post-procedure
Title
All cause mortality
Time Frame
At 6 months post-procedure
Title
Retreatment
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Weber, PD Dr. med
Organizational Affiliation
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asklepios Klinik Altona
City
Hamburg
Country
Germany
Facility Name
Universitätsklinikum des Saarlandes
City
Homburg/Saar
Country
Germany
Facility Name
Universitätsklinikum Magdeburg A. ö. R.
City
Magdeburg
Country
Germany
Facility Name
Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen
City
Recklinghausen
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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