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Aneurysm Study of Pipeline in an Observational Registry (ASPIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01557036
Recruitment Status : Terminated
First Posted : March 19, 2012
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

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.

Condition or disease Intervention/treatment
Brain Aneurysm Device: Pipeline Embolization Device

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Aneurysm Study of Pipeline in an Observational Registry
Study Start Date : May 2012
Actual Primary Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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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
Study Population
Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.
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.

Information from the National Library of Medicine

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


Locations
Show Show 36 study locations
Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT01557036    
Other Study ID Numbers: PED002
First Posted: March 19, 2012    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015
Keywords provided by Medtronic Neurovascular Clinical Affairs:
Brain Aneurysm
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases