Neurovascular Product Surveillance Registry (NV PSR INSPIRE) Pipeline™ Vantage Embolization Device With Shield Technology™ Post Approval Study (PAS)
Medtronic Neurovascular Clinical Affairs
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 treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.
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 aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™. This study is a sub-study to the Neurovascular Product Surveillance Registry (NCT02988128).
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- Not specified
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 cont…
Interventions
- DeviceTreatment of Intracranial Aneurysms
Embolization of aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™
Locations (4)
- Wellstar Research InstituteMarietta, Georgia
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- McLaren HealthcareFlint, Michigan
- Semmes Murphey Clinic/Semmes Murphy FoundationMemphis, Tennessee