INSPIRE Pipeline™ Shield Post Approval Study (NCT05071963) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
INSPIRE Pipeline™ Shield Post Approval Study
United States246 participantsStarted 2021-12-20
Plain-language summary
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Shield PAS") is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex Embolization Device with Shield Technology™ ("Pipeline™ Shield Device") in a real-world post approval setting within the United States.
Who can participate
Age range
22 Years
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
. Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
. Patient is intended to receive or be treated with an eligible Medtronic product.
. Patient is consented within the enrollment window of the therapy received, as applicable.
. Patient or patient's legally authorized representative (LAR) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with the study requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR).
. Patient has already been selected for endovascular treatment of the target aneurysm with the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™ Shield Device Instructions For Use (IFU).
Exclusion criteria
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 the composite outcome (Occlusion of the target aneurysm, Significant parent artery stenosis, Retreatment of the target aneurysm) at 1 year post-procedure.
. Patient who is, or is expected to be, inaccessible for follow-up.
. Participation is excluded by local law.
. Patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the PSR results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness).
. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
. Patient is contraindicated for the device or procedure per the Pipeline™ Shield Device IFU.
. The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
. Patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from Medtronic.