NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

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).

Inclusion criteria

• 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 criteria

• 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.