Aneurysm Study of Pipeline in an Observational Registry (ASPIRE)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Brain Aneurysm |
Device: Pipeline Embolization Device |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Aneurysm Study of Pipeline in an Observational Registry |
- 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 ] [ Designated as safety issue: Yes ]
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
| Estimated Enrollment: | 1500 |
| Study Start Date: | May 2012 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Aneurysms treated with Pipleline
Aneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device
|
Device: Pipeline Embolization Device
Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.
Other Name: PED
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.
Inclusion Criteria:
(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
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)
- 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.
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| Barrow Neurosurgical Associates | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Ronald Reagan UCLA Medical Center | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| Radiology Imaging Associates / Colorado Neurological Institute | |
| Englewood, Colorado, United States, 80113 | |
| United States, Florida | |
| Mayo Clinic | |
| Jacksonville, Florida, United States, 32224 | |
| Neurointerventional Associates, P.A. | |
| St. Petersburg, Florida, United States, 33701 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| United States, Kentucky | |
| Neurosurgical Associates at Central Baptist | |
| Lexington, Kentucky, United States, 40503 | |
| Norton Neuroscience Institute | |
| Louisville, Kentucky, United States, 40241 | |
| United States, Minnesota | |
| Abbott Northwestern Hospital/Consulting Radiologists | |
| Minneapolis, Minnesota, United States, 55407 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New York | |
| University of Buffalo Neurosurgery, Buffalo General Hospital | |
| Buffalo, New York, United States, 14203 | |
| The State University of New York, Stony Brook | |
| Stony Brook, New York, United States, 11794 | |
| United States, Ohio | |
| The Ohio State University Wexner Medical Center | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Oregon Health and Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Thomas Jefferson University Hospital | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Texas | |
| The Methodist Hospital | |
| Houston, Texas, United States, 77030 | |
| St. Luke's Episcopal Hospital | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| Medical College Of Wisconsin/Froedtert Hospital | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Argentina | |
| Clínica La Sagrada Familia | |
| Buenos Aires, Argentina, C1426EOB | |
| Canada, Saskatchewan | |
| Royal University Hospital | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| France | |
| Hôpital Gui de Chauliac | |
| Montpellier, France, 34295 | |
| Germany | |
| Klinikum Stuttgart | |
| Stuttgart, Germany, 70174 | |
| Italy | |
| Niguarda CA Granda Hospital of Milan | |
| Milan, Italy, 20162 | |
| Fondazione Istituto Neurologico "Besta" | |
| Milano, Italy, 20133 | |
More Information
No publications provided
| Responsible Party: | ev3 |
| ClinicalTrials.gov Identifier: | NCT01557036 History of Changes |
| Other Study ID Numbers: | PED002 |
| Study First Received: | March 13, 2012 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by ev3:
|
Brain Aneurysm |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013