Status:
NOT_YET_RECRUITING
NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study
Lead Sponsor:
Medtronic Neurovascular Clinical Affairs
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
22+ years
Brief Summary
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 ...
Detailed Description
The INSPIRE Pipeline™ Vantage Post Approval Study is a, prospective, multi-center, single-arm clinical study to collect safety and effectiveness data in patients undergoing treatment for intracranial ...
Eligibility Criteria
Inclusion
- 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.
- Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™.
- Patient is an adult per local law at time of consent.
Exclusion
- Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU.
- Patient who may be unable to complete the study follow-up.
- The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
- Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
- Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2033
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT06604884
Start Date
December 1 2025
End Date
September 1 2033
Last Update
December 17 2025
Active Locations (1)
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1
McLaren Healthcare
Flint, Michigan, United States, 48532