Aneurysm Study of Pipeline in an Observational Registry (ASPIRE)
|First Received Date ICMJE||March 13, 2012|
|Last Updated Date||November 5, 2013|
|Start Date ICMJE||May 2012|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01557036 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Aneurysm Study of Pipeline in an Observational Registry|
|Official Title ICMJE||Aneurysm Study of Pipeline in an Observational Registry|
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.
|Detailed Description||Not Provided|
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Non-Probability Sample|
Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.
|Condition ICMJE||Brain Aneurysm|
|Intervention ICMJE||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
|Study Group/Cohort (s)||Aneurysms treated with Pipleline
Aneurysms treated with Pipleline. All patients independently treated according to the labeled indications for use with the Pipeline Embolization Device
Intervention: Device: Pipeline Embolization Device
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Enrolling by invitation|
|Estimated Enrollment ICMJE||1500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
(All sites, All countries)
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)
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States, Argentina, Canada, France, Germany, Italy, Switzerland|
|NCT Number ICMJE||NCT01557036|
|Other Study ID Numbers ICMJE||PED002|
|Has Data Monitoring Committee||Yes|
|Study Sponsor ICMJE||ev3|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|Information Provided By||ev3|
|Verification Date||November 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP