Brain AneurysmASPIRENCT01557036
Aneurysm Study of Pipeline in an Observational Registry
An observational study of Brain Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 36 sites in 8 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Aneurysm
- What is being tested?
- Pipeline Embolization Device
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 36 sitesin 8 countries
- Study dates
- 21 Jun 2012to 5 Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.
Who may be able to join
- (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
- 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
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- 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.
Who cannot join
- 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.
Trial locations and contacts
36 sites in 8 countries.
36 sites in 8 countries
United States24 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of Buffalo Neurosurgery, Buffalo General Hospital
Buffalo, New York, 14203
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush University Medical Center
Chicago, Illinois, 60612
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
Radiology Imaging Associates / Colorado Neurological Institute
Englewood, Colorado, 80113
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
St. Luke's Episcopal Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
Mayo Clinic
Jacksonville, Florida, 32224
Neurosurgical Associates at Central Baptist
Lexington, Kentucky, 40503
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90095
Norton Neuroscience Institute
Louisville, Kentucky, 40241
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
Medical College Of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226
Abbott Northwestern Hospital/Consulting Radiologists
Minneapolis, Minnesota, 55407
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Barrow Neurosurgical Associates
Phoenix, Arizona, 85013
Oregon Health and Science University
Portland, Oregon, 97239
Mayo Clinic
Rochester, Minnesota, 55905
St. Paul Radiology
Saint Paul, Minnesota, 55102
Washington University
St Louis, Missouri, 63110
Neurointerventional Associates, P.A.
St. Petersburg, Florida, 33701
The State University of New York, Stony Brook
Stony Brook, New York, 11794
France3 sites
Besançon University Hospital
Besançon, 25030
Hôpital Gui de Chauliac
Montpellier, 34295
Hôpital Maison Blanche - CHU
Reims, 51100
Italy3 sites
Niguarda CA Granda Hospital of Milan
Milan, 20162
Fondazione Istituto Neurologico "Besta"
Milan, 20133
Ospedale San Giovanni Bosco ASL Napoli 1 Centro
Naples, 80144
Germany2 sites
Alfried Krupp Krankenhaus
Essen, 45131
Klinikum Stuttgart
Stuttgart, 70174
About this study
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.
- Conditions
- Brain Aneurysm
- Being tested
- Pipeline Embolization Device
- Keywords
- Brain Aneurysm
- Medical subject headings
- Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pipeline Embolization DeviceDevice
Also called PED
Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.
| Study group | Role | What they receive |
|---|---|---|
| Aneurysms treated with Pipleline | Aneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device Receives: Device: Pipeline Embolization Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2012 (estimated)
- Study start21 Jun 2012
- Primary completion7 May 2014
- Study completion5 Jun 2014
Why it stopped: The ASPIRe registry was stopped after only 200 patients were enrolled as this was deemed sufficient to confirm the safety event rates that had recently been identified in the lntrePED registry.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01557036
- Sponsor's protocol ID
- PED002
- Acronym
- ASPIRE
- Status last verified
- Jun 2026
- First submitted
- 13 Mar 2012
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aneurysm Study of Pipeline in an Observational Registry
- ClinicalTrials.gov ID
- NCT01557036
- Acronym / sponsor ID
- ASPIRE / PED002
- Conditions
- Brain Aneurysm
- Keywords
- Brain Aneurysm
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The ASPIRe registry was stopped after only 200 patients were enrolled as this was deemed sufficient to confirm the safety event rates that had recently been identified in the lntrePED registry.
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2012 (actual)
- Primary completion
- 7 May 2014 (actual)
- Study completion
- 5 Jun 2014 (actual)
- First posted
- 19 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aneurysms treated with Pipleline | – | Device: Pipeline Embolization DeviceAneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.
Key inclusion criteria (12 listed)
- (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
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pipeline Embolization DeviceAlso: PEDAneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study. | Device | Aneurysms treated with Pipleline |
Primary outcome
Incidence of Neurological Adverse Events following PED use
Time frame: From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled
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
Results and safety
The study was stopped early (reason given: The ASPIRe registry was stopped after only 200 patients were enrolled as this was deemed sufficient to confirm the safety event rates that had recently been identified in the lntrePED registry.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Aneurysm, run by Medtronic Neurovascular Clinical Affairs at 36 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in United States, France, Italy, Germany, Argentina and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The ASPIRe registry was stopped after only 200 patients were enrolled as this was deemed sufficient to confirm the safety event rates that had recently been identified in the lntrePED registry.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Neurological Adverse Events following PED use (time frame: From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.