RecruitingNCT02988128
Neurovascular Product Surveillance Registry
NeuroVascular Product Surveillance Registry (PSR) Platform
Sponsor
Medtronic Neurovascular Clinical Affairs
Enrollment
4,000 participants
Start Date
Dec 1, 2016
Study Type
OBSERVATIONAL
Conditions
Summary
Post market surveillance registry
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- For MDT16056 and MDT17077
- 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.
- 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
Exclusion Criteria9
- Patient who is, or is expected to be inaccessible for follow-up
- 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:
- 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.
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Interventions
DEVICETreatment for intracranial aneurysms
Embolization of aneurysms
DEVICETreatment for Acute Ischemic Stroke
Revascularization of an intracranial blood vessel
Locations(99)
View Full Details on ClinicalTrials.gov
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NCT02988128
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