Clinical trial NCT01557036: Aneurysm Study of Pipeline in an Observational Registry
Official title: Aneurysm Study of Pipeline in an Observational Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Brain Aneurysm
Keywords: Brain Aneurysm
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Neurological Adverse Events following PED use
timeFrame: From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Barrow Neurosurgical Associates
state: Arizona
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center
state: California
city: Englewood
country: United States
facility: Radiology Imaging Associates / Colorado Neurological Institute
state: Colorado
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: St. Petersburg
country: United States
facility: Neurointerventional Associates, P.A.
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Lexington
country: United States
facility: Neurosurgical Associates at Central Baptist
state: Kentucky
city: Louisville
country: United States
facility: Norton Neuroscience Institute
state: Kentucky
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital/Consulting Radiologists
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: St. Paul
country: United States
facility: St. Paul Radiology
state: Minnesota
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: Buffalo
country: United States
facility: University of Buffalo Neurosurgery, Buffalo General Hospital
state: New York
city: Stony Brook
country: United States
facility: The State University of New York, Stony Brook
state: New York
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: St. Luke's Episcopal Hospital
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin/Froedtert Hospital
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Clínica La Sagrada Familia
city: Ghent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Besançon
country: France
facility: Besançon University Hospital
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Reims
country: France
facility: Hôpital Maison Blanche - CHU
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus
city: Stuttgart
country: Germany
facility: Klinikum Stuttgart
city: Milano
country: Italy
facility: Fondazione Istituto Neurologico "Besta"
city: Milan
country: Italy
facility: Niguarda CA Granda Hospital of Milan
city: Napoli
country: Italy
facility: Ospedale San Giovanni Bosco ASL Napoli 1 Centro
city: Geneva
country: Switzerland
facility: University Hospitals of Geneva (HUG)
Study officials:
References: