Aneurysm Study of Pipeline in an Observational Registry
ASPIRE
1 other identifier
observational
200
8 countries
36
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 13, 2012
CompletedFirst Posted
Study publicly available on registry
March 19, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedJanuary 21, 2015
January 1, 2015
2 years
March 13, 2012
January 19, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Aneurysms treated with Pipleline
Aneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device
Interventions
Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.
Eligibility Criteria
Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.
You may qualify if:
- (All sites, All countries)
- At least 1 Pipeline placed for treatment of an ICA
- Patient or patient's Legally Authorized Representative (LAR) has signed an IRB- or EC-approved informed consent form, if required
- Patient is willing and able to comply with follow-up visits
- US) 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
- C) 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.
- C) Canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter.
- F) 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.
- F) IA previously treated with unruptured recanalization of the aneurismal sac \> 7 mm, not treatable with conservative treatment.
You may not qualify if:
- Active bacterial infection
- A patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated
- A patient who has not received dual antiplatelet agents prior to the procedure
- Pre-existing stent is in place in the parent artery at the target aneurysm location
- Angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Barrow Neurosurgical Associates
Phoenix, Arizona, 85013, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095, United States
Radiology Imaging Associates / Colorado Neurological Institute
Englewood, Colorado, 80113, United States
Mayo Clinic
Jacksonville, Florida, 32224, United States
Neurointerventional Associates, P.A.
St. Petersburg, Florida, 33701, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Neurosurgical Associates at Central Baptist
Lexington, Kentucky, 40503, United States
Norton Neuroscience Institute
Louisville, Kentucky, 40241, United States
Abbott Northwestern Hospital/Consulting Radiologists
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St. Paul Radiology
Saint Paul, Minnesota, 55102, United States
Washington University
St Louis, Missouri, 63110, United States
University of Buffalo Neurosurgery, Buffalo General Hospital
Buffalo, New York, 14203, United States
The State University of New York, Stony Brook
Stony Brook, New York, 11794, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
St. Luke's Episcopal Hospital
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Medical College Of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Clínica La Sagrada Familia
Buenos Aires, C1426EOB, Argentina
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8, Canada
Besançon University Hospital
Besançon, 25030, France
Hôpital Gui de Chauliac
Montpellier, 34295, France
Hôpital Maison Blanche - CHU
Reims, 51100, France
Alfried Krupp Krankenhaus
Essen, 45131, Germany
Klinikum Stuttgart
Stuttgart, 70174, Germany
Niguarda CA Granda Hospital of Milan
Milan, 20162, Italy
Fondazione Istituto Neurologico "Besta"
Milan, 20133, Italy
Ospedale San Giovanni Bosco ASL Napoli 1 Centro
Napoli, 80144, Italy
University Hospitals of Geneva (HUG)
Geneva, 1211, Switzerland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 13, 2012
First Posted
March 19, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2014
Last Updated
January 21, 2015
Record last verified: 2015-01