RecruitingIntracranial Aneurysm

NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

Eligible age

22+ yrs

Accepts

All genders

Locations

9 states

Healthy volunteers

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About this 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.

Sponsor: Medtronic Neurovascular Clinical Affairs

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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.