Aneurysm Study of Pipeline in an Observational Registry (ASPIRE)

• ClinicalTrials.gov Identifier: NCT01557036
• Recruitment Status: Terminated
• First Posted: March 19, 2012
• Last Update Posted: January 21, 2015
• Sponsor: Medtronic Neurovascular Clinical Affairs
• Information provided by (Responsible Party): Medtronic Neurovascular Clinical Affairs

Tracking Information

• First Submitted Date: March 13, 2012
• First Posted Date: March 19, 2012
• Last Update Posted Date: January 21, 2015
• Study Start Date: May 2012
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 15, 2012)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Aneurysm Study of Pipeline in an Observational Registry
• Official Title: Aneurysm Study of Pipeline in an Observational Registry
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with an intracranial aneurysm meeting the labeled indication for the relevant geography.
• Condition: Brain Aneurysm

Intervention

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 Groups/Cohorts

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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: January 19, 2015): 200
• Original Estimated Enrollment (submitted: March 15, 2012): 1500
• Study Completion Date: Not Provided
• Actual Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Argentina, Belgium, Canada, France, Germany, Italy, Switzerland, United States

Administrative Information

• NCT Number: NCT01557036
• Other Study ID Numbers: PED002
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Medtronic Neurovascular Clinical Affairs
• Original Responsible Party: Same as current
• Current Study Sponsor: Medtronic Neurovascular Clinical Affairs
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Medtronic Neurovascular Clinical Affairs
• Verification Date: January 2015