Aneurysm Study of Pipeline in an Observational Registry (NCT01557036) | Clinical Trial Compass
TerminatedNot Applicable
Aneurysm Study of Pipeline in an Observational Registry
Stopped: The ASPIRe registry was stopped after only 200 patients were enrolled as this was deemed sufficient to confirm the safety event rates that had recently been identified in the lntrePED registry.
United States, Argentina, Belgium200 participantsStarted 2012-06-21
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Neurological Adverse Events following PED use
Timeframe: From Device placement until last follow up, for an average of 3 years of follow up for each subject enrolled
. 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.