Aneurysm Study of Pipeline in an Observational Registry
NCT ID: NCT01557036
Last Updated: 2015-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
200 participants
OBSERVATIONAL
2012-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nomogram for Predicting In-stent Stenosis After Pipeline Embolization Device Treatment in Patients with Intracranial Aneurysm
NCT06715930
Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment
NCT02812108
Complete Occlusion of Coilable Aneurysms
NCT00777907
Pipeline Embolization Device for the Treatment of Intracranial Aneurysms on the Long Term Safety and Efficacy
NCT06456697
Pipeline Embolization for Intracranial Aneurysms
NCT06446778
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Aneurysms treated with Pipleline
Aneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device
Pipeline Embolization Device
Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pipeline Embolization Device
Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
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.
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
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.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Barrow Neurosurgical Associates
Phoenix, Arizona, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Radiology Imaging Associates / Colorado Neurological Institute
Englewood, Colorado, United States
Mayo Clinic
Jacksonville, Florida, United States
Neurointerventional Associates, P.A.
St. Petersburg, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
Neurosurgical Associates at Central Baptist
Lexington, Kentucky, United States
Norton Neuroscience Institute
Louisville, Kentucky, United States
Abbott Northwestern Hospital/Consulting Radiologists
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Paul Radiology
Saint Paul, Minnesota, United States
Washington University
St Louis, Missouri, United States
University of Buffalo Neurosurgery, Buffalo General Hospital
Buffalo, New York, United States
The State University of New York, Stony Brook
Stony Brook, New York, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health and Science University
Portland, Oregon, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
St. Luke's Episcopal Hospital
Houston, Texas, United States
The Methodist Hospital
Houston, Texas, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Medical College Of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States
Clínica La Sagrada Familia
Buenos Aires, , Argentina
Universitair Ziekenhuis Gent
Ghent, , Belgium
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Besançon University Hospital
Besançon, , France
Hôpital Gui de Chauliac
Montpellier, , France
Hôpital Maison Blanche - CHU
Reims, , France
Alfried Krupp Krankenhaus
Essen, , Germany
Klinikum Stuttgart
Stuttgart, , Germany
Niguarda CA Granda Hospital of Milan
Milan, , Italy
Fondazione Istituto Neurologico "Besta"
Milan, , Italy
Ospedale San Giovanni Bosco ASL Napoli 1 Centro
Napoli, , Italy
University Hospitals of Geneva (HUG)
Geneva, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PED002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.