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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01557036
Other study ID # PED002
Secondary ID
Status Terminated
Phase N/A
First received March 13, 2012
Last updated January 19, 2015
Start date May 2012

Study information

Verified date January 2015
Source ev3
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.


Recruitment information / eligibility

Status Terminated
Enrollment 200
Est. completion date
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

(All sites, All countries)

1. At least 1 Pipeline placed for treatment of an ICA

2. Patient or patient's Legally Authorized Representative (LAR) has signed an IRB- or EC-approved informed consent form, if required

3. Patient is willing and able to comply with follow-up visits

United States: Additional Inclusion Criteria for subjects enrolled in the United States:

4US) Subjects who are age 22 or higher 5US) IA of at least 10 mm in maximum dimension along the internal carotid artery between the petrous and superior hypophyseal segments

Canada: Additional Inclusion Criteria for subjects enrolled in Canada:

4C) In Canada, the Pipelineā„¢ Embolization Device is intended for use with or without embolic coils for the treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping.

5C) Canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter.

France: Additional Inclusion Criteria for subjects enrolled in France:

4F) Unruptured IA, saccular or fusiform with an aneurysm sac diameter > 15mm and not treatable with other current therapies ( EVT with coils with or without assisting system (intracranial stent) or balloon remodeling, or surgery) due to its specific morphology.

5F) IA previously treated with unruptured recanalization of the aneurismal sac > 7 mm, not treatable with conservative treatment.

Exclusion Criteria: (based on contraindications PED IFU)

1. Active bacterial infection

2. A patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated

3. A patient who has not received dual antiplatelet agents prior to the procedure

4. Pre-existing stent is in place in the parent artery at the target aneurysm location

5. Angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing

6. Acutely ruptured aneurysm, defined as rupture of the target aneurysm Each site should refer to their country specific Instructions for Use/Approval(France) to determine final eligibility into the ASPIRe Registry.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Device:
Pipeline Embolization Device
Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.

Locations

Country Name City State
Argentina Clínica La Sagrada Familia Buenos Aires
Belgium Universitair Ziekenhuis Gent Ghent
Canada Royal University Hospital Saskatoon Saskatchewan
France Besançon University Hospital Besançon
France Hôpital Gui de Chauliac Montpellier
France Hôpital Maison Blanche - CHU Reims
Germany Alfried Krupp Krankenhaus Essen
Germany Klinikum Stuttgart Stuttgart
Italy Niguarda CA Granda Hospital of Milan Milan
Italy Fondazione Istituto Neurologico "Besta" Milano
Italy Ospedale San Giovanni Bosco ASL Napoli 1 Centro Napoli
Switzerland University Hospitals of Geneva (HUG) Geneva
United States University of Alabama at Birmingham Birmingham Alabama
United States University of Buffalo Neurosurgery, Buffalo General Hospital Buffalo New York
United States Medical University of South Carolina Charleston South Carolina
United States Rush University Medical Center Chicago Illinois
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Radiology Imaging Associates / Colorado Neurological Institute Englewood Colorado
United States Penn State Milton S. Hershey Medical Center Hershey Pennsylvania
United States St. Luke's Episcopal Hospital Houston Texas
United States The Methodist Hospital Houston Texas
United States Mayo Clinic Jacksonville Florida
United States Neurosurgical Associates at Central Baptist Lexington Kentucky
United States Ronald Reagan UCLA Medical Center Los Angeles California
United States Norton Neuroscience Institute Louisville Kentucky
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Medical College Of Wisconsin/Froedtert Hospital Milwaukee Wisconsin
United States Abbott Northwestern Hospital/Consulting Radiologists Minneapolis Minnesota
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Barrow Neurosurgical Associates Phoenix Arizona
United States Oregon Health and Science University Portland Oregon
United States Mayo Clinic Rochester Minnesota
United States Washington University St. Louis Missouri
United States St. Paul Radiology St. Paul Minnesota
United States Neurointerventional Associates, P.A. St. Petersburg Florida
United States The State University of New York, Stony Brook Stony Brook New York

Sponsors (1)

Lead Sponsor Collaborator
ev3

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  France,  Germany,  Italy,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Neurological Adverse Events following PED use The primary endpoint will consist of a composite of any/all of the events listed below.
Incidence of spontaneous rupture of Pipeline treated aneurysm
Incidence of other (non-aneurysmal) intracranial hemorrhage, ipsilateral and contralateral
Incidence of ischemic stroke
Incidence of symptomatic and asymptomatic parent artery stenosis
Incidence of permanent cranial neuropathy
Incidence of change in baseline neurologic signs/symptoms related to Pipeline treated ICA(s) at last assessment
From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled Yes
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