Neurovascular Product Surveillance Registry

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.