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

Wide Neck Intracranial Aneurysms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01753388
• Other study ID #: CLP 4928
• Secondary ID: CLP 4928
• Status: Withdrawn
• Phase: Phase 2
• Start date: December 2012
• Est. completion date: June 2017

Study information

• Verified date: April 2019
• Source: Penumbra Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Wide Neck Intracranial Aneurysms

Intervention

Device:
• Liberty Stent

Locations

Country	Name	City	State
Germany	Asklepios Klinik Altona	Hamburg
Germany	Universitätsklinikum des Saarlandes	Homburg/Saar
Germany	Universitätsklinikum Magdeburg A. ö. R.	Magdeburg
Germany	Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen	Recklinghausen

Sponsors (1)

Lead Sponsor	Collaborator
Penumbra Inc.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Procedural device-related serious adverse events		During the procedure
Secondary	Device patency and migration		At 6 months post-procedure
Secondary	Intracranial hemorrhage		At 6 months post-procedure
Secondary	Functional outcome as defined by the modified Rankin Scale (mRS)		At 6 months post-procedure
Secondary	All cause mortality		At 6 months post-procedure
Secondary	Retreatment		At 6 months