INSPIRE Pipeline™ Shield Post Approval Study

Recruiting in Palo Alto (17 mi)

+15 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic Neurovascular Clinical Affairs

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

Inclusion Criteria

Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.

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).

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Treatment Details

Interventions

Pipeline™ Flex Embolization Device with Shield Technology™ (Procedure)

Pipeline™ Flex Embolization Device with Shield Technology™ is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Pipeline Flex Embolization Device with Shield Technology for:

Endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (IAs) in the internal carotid artery from the petrous to the superior hypophyseal segments
Endovascular treatment of adults (22 years of age or older) with small and medium wide-necked (neck width 4 mm or dome-to-neck ratio < 2) saccular or fusiform intracranial aneurysm (IAs) arising from a parent vessel with a diameter 2.0 mm and ≤ 5.0 mm

🇪🇺 Approved in European Union as Pipeline Flex Embolization Device with Shield Technology for: