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NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
Neurovascular Product Surveillance Registry (NV PSR INSPIRE) Pipeline™ Vantage Embolization Device With Shield Technology™ Post Approval Study (PAS)
Who can join
Ages 22 and older · All sexes
Full eligibility criteria
Inclusion Criteria: 1. Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law. 2. Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™. 3. Patient is an adult per local law at time of consent. Exclusion Criteria: 1. Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU. 2. Patient who may be unable to complete the study follow-up. 3. The Investigator determined that the health of the patient may be compromised by the patient's enrollment. 4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study. 5. Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
About the study
The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.
What is being tested
- Treatment of Intracranial Aneurysms (device)
Sponsor: Medtronic Neurovascular Clinical Affairs · Participants: 118 · Started: Dec 12, 2025
Contact the study team
- Medtronic Neurovascular Clinical Affairs · Phone: 949-837-3700
Official record on ClinicalTrials.gov — NCT06604884
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.