Overview
Post market surveillance registry
Description
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).
Eligibility
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.


