Neurovascular Product Surveillance Registry

NeuroVascular Product Surveillance Registry (PSR) Platform

Post market surveillance registry

An observational, prospective, multi-center, single-arm registry to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic Neurovascular market-released products used in the treatment of Intracranial aneurysms and Acute Ischemic Stroke.

MDT16056 and MDT17077 are conducted under the Product Surveillance Registry (NCT01524276).

For MDT16056 and MDT17077

Inclusion Criteria:

• Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements
• Patient has, or 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 is at least 18 years of age at time of enrollment.

Exclusion Criteria:

• Patient who is, or is expected to be inaccessible for follow-up
• Patient with exclusion criteria required by local law
• Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results
• Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study.

For MDT24028 and MDT22032:

General Inclusion Criteria:

• Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
• Patient is treated or intended to be treated with an eligible Medtronic Neurovascular product.
• Patient is an adult per local law at time of consent. Medtronic Business Restricted This document is electronically controlled CONFIDENTIAL 056-F275 Rev F Clinical Investigation Plan Template

General Exclusion Criteria:

• Patient who may be unable to complete the study follow-up
• Patient with any contraindications per the applicable Instructions for Use document
• 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.

Additional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.