INSPIRE Pipeline™ Shield Post Approval Study

The INSPIRE Pipeline™ Shield Post Approval Study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™ according to the intended use.

The primary objective of this study is to evaluate the on-label use of the Pipeline™ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S.

This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128).

Inclusion criteria

• Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
• Patient is intended to receive or be treated with an eligible Medtronic product.
• Patient is consented within the enrollment window of the therapy received, as applicable.
• Patient or patient's legally authorized representative (LAR) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with the study requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR).
• Patient has already been selected for endovascular treatment of the target aneurysm with the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™ Shield Device Instructions For Use (IFU).

Exclusion criteria

• Patient who is, or is expected to be, inaccessible for follow-up.
• Participation is excluded by local law.
• Patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the PSR results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness).
• Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.
• Patient is contraindicated for the device or procedure per the Pipeline™ Shield Device IFU.
• The Investigator determined that the health of the patient may be compromised by the patient's enrollment.
• Patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from Medtronic.