Neurovascular Product Surveillance Registry (INSPIRE)

Medtronic

Status

Enrolling

Conditions

Intracranial Aneurysm

Stroke, Ischemic

Treatments

Device: Treatment for Acute Ischemic Stroke

Device: Treatment for intracranial aneurysms

Study type

Observational

Funder types

Industry

Identifiers

NCT02988128

MDT16056/17077/24028/22032

Details and patient eligibility

About

Post market surveillance registry

Full 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).

Enrollment

4,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.