Neurovascular Product Surveillance Registry

Launched by MEDTRONIC NEUROVASCULAR CLINICAL AFFAIRS · Dec 7, 2016

Keywords

ClinConnect Summary

The Neurovascular Product Surveillance Registry is a clinical trial designed to monitor the safety and effectiveness of certain medical products used to treat conditions like intracranial aneurysms, strokes, and ischemia. This study is currently recruiting participants who are at least 18 years old and either have been treated with, or are planned to be treated with, specific Medtronic neurovascular products. Participants will need to give their consent to join the study, which means they agree to share information about their treatment and health for research purposes.

To be eligible, participants must be able to complete the follow-up required for the study and cannot be pregnant, breastfeeding, or planning to become pregnant during the study. Those who are currently involved in other similar studies that could affect the results of this trial will also be excluded. If you choose to participate, you can expect to provide updates on your health and treatment over time, which will help researchers understand how well these products work in real-world situations.

Gender

ALL

Eligibility criteria

• • 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.