Aneurysm Study of Pipeline in an Observational Registry

Terminated

• Conditions: Brain Aneurysm

• Registration Number: NCT01557036
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-13
• Study First Submitted QC: 2012-03-15
• Study First Posted: 2012-03-19
• Study Start: 2012-05
• Primary Completion: 2014-05
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Neurological Adverse Events following PED use	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

Trial Locations

Locations (35)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Barrow Neurosurgical Associates; 🇺🇸 Phoenix, Arizona, United States

Ronald Reagan UCLA Medical Center; 🇺🇸 Los Angeles, California, United States

Radiology Imaging Associates / Colorado Neurological Institute; 🇺🇸 Englewood, Colorado, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Neurointerventional Associates, P.A.; 🇺🇸 St. Petersburg, Florida, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Neurosurgical Associates at Central Baptist; 🇺🇸 Lexington, Kentucky, United States

Norton Neuroscience Institute; 🇺🇸 Louisville, Kentucky, United States

Abbott Northwestern Hospital/Consulting Radiologists; 🇺🇸 Minneapolis, Minnesota, United States

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