Aneurysm Study of Pipeline in an Observational Registry (ASPIRE)
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|ClinicalTrials.gov Identifier: NCT01557036|
Recruitment Status : Terminated
First Posted : March 19, 2012
Last Update Posted : January 21, 2015
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|Condition or disease||Intervention/treatment|
|Brain Aneurysm||Device: Pipeline Embolization Device|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Aneurysm Study of Pipeline in an Observational Registry|
|Study Start Date :||May 2012|
|Actual Primary Completion Date :||May 2014|
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
- 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
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
(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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01557036
|Responsible Party:||Medtronic Neurovascular Clinical Affairs|
|Other Study ID Numbers:||
|First Posted:||March 19, 2012 Key Record Dates|
|Last Update Posted:||January 21, 2015|
|Last Verified:||January 2015|
Intracranial Arterial Diseases
Central Nervous System Diseases
Nervous System Diseases