Registry for monitoring neurovascular products used in treating brain aneurysms and strokes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry aims to continuously evaluate and report on the safety and effectiveness of Medtronic Neurovascular products used for treating intracranial aneurysms and acute ischemic strokes. It involves a multi-center, single-arm approach where patients receiving eligible Medtronic devices are monitored over time. The registry collects data on patient outcomes to ensure ongoing assessment of these medical devices in real-world settings.

Why it matters

Who can join: the full rules

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.

Where it's running

• Eneri
  Buenos Aires, Argentina Recruiting
• Universitätsklinikum Christian Doppler Klinik Salzburg
  Salzburg, Austria Recruiting
• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Turun Yliopistollinen keskussairaala
  Turku, Finland Recruiting
• CHU Besancon - Hôpital Jean Minjoz
  Besançon, France Recruiting
• CHU Brest, Hôpital de la Cavale Blanche
  Brest, France Recruiting

+49 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Wouter Fabry
• Email: wouter.fabry@medtronic.com
• Phone: +32496165078

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.