Aneurysm Study of Pipeline in an Observational Registry

Brain Aneurysm Clinical Trial

— ASPIRE  

Official title:

Aneurysm Study of Pipeline in an Observational Registry

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01557036
• Other study ID #: PED002
• 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. 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 Pipeline™ 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

• Aneurysm
• Brain Aneurysm

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