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

NeuroVascular Product Surveillance Registry (PSR) Platform

This study is tracking how well Medtronic devices work and their safety for people being treated for brain aneurysms and strokes.

Quick facts

• Study type: Observational
• Enrollment: 4000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medtronic Neurovascular Clinical Affairs (Industry-sponsored)
• Locations: 99 sites (Buenos Aires and 98 other locations)
• Trial ID: NCT02988128 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are receiving or are intended to receive eligible Medtronic neurovascular products.

Not a fit: Patients who are pregnant, breastfeeding, or enrolled in conflicting studies may not benefit from this registry.

Why it matters

Potential benefit: If successful, this registry could enhance the safety and effectiveness of treatments for patients with intracranial aneurysms and strokes.

How similar studies have performed: Other observational registries have shown success in monitoring medical devices, indicating that this approach is supported by prior evidence.

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.

Where this trial is running

Buenos Aires and 98 other locations

• Eneri — Buenos Aires, Argentina (Completed)
• Gold Coast University Hospital — Southport, Australia (Active_not_recruiting)
• Universitätsklinikum Christian Doppler Klinik Salzburg — Salzburg, Austria (Recruiting)
• Ziekenhuis Oost Limburg - Campus Sint-Jan — Genk, Belgium (Completed)
• Universitair Ziekenhuis Gent — Ghent, Belgium (Completed)
• Xuanwu Hospital Capital Medical University — Beijing, China (Completed)
• Chongqing University Three Gorges Hospital — Chongqing, China (Completed)
• First Affiliated Hospital of Jiamusi University — Jiamusi, China (Terminated)
• The Affiliated Hospital of Jinggangshan University — Ji’an, China (Completed)
• Kaifeng Central Hospital — Kaifeng, China (Terminated)
• Liaocheng People's Hospital — Liaocheng, China (Terminated)
• Lishui Municipal Central Hospital — Lishui, China (Terminated)
• The Second Affiliated Hospital of Nanchang University — Nanchang, China (Terminated)
• The Second Nanning Peoples Hospital — Nanning, China (Completed)
• Panzhihua Central Hospital — Panzhihua, China (Terminated)
• Qujing First Peoples Hospital — Qujing, China (Terminated)
• Yangpu District Central Hospital Shanghai Yangpu Hospital Tongji University — Shanghai, China (Completed)
• Shanxi Cardiovascular Hospital — Taiyuan, China (Completed)
• The First Affiliated Hospital Of Xi'an Jiaotong University — Xi'an, China (Completed)
• The First Peoples Hospital of Xianyang — Xianyang, China (Completed)
• Zhangzhou Municipal Hospital of Fujian Province — Zhangzhou, China (Completed)
• Zhuhai Peoples Hospital — Zhuhai, China (Terminated)
• Zhumadian Central Hospital — Zhumadian, China (Completed)
• Rigshospitalet — Copenhagen, Denmark (Recruiting)
• Turun Yliopistollinen keskussairaala — Turku, Finland (Recruiting)
• CHU Besancon - Hôpital Jean Minjoz — Besançon, France (Active_not_recruiting)
• CHU de Bordeaux - Centre Universitaire Pellegrin — Bordeaux, France (Completed)
• CHU Brest, Hôpital de la Cavale Blanche — Brest, France (Recruiting)
• Hôpital Pierre Wertheimer — Bron, France (Recruiting)
• CHU de Caen — Caen, France (Completed)
• Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied — Clermont-Ferrand, France (Completed)
• CHU Dijon Bourgogne — Dijon, France (Completed)
• AP-HP Hôpital Bicêtre — Le Kremlin-Bicêtre, France (Recruiting)
• CHU Limoges - Hôpital Dupuytren — Limoges, France (Recruiting)
• Hôpital de la Timone-CHU de Marseille — Marseille, France (Recruiting)
• CHU de Montpellier - Hôpital Gui de Chauliac — Montpellier, France (Recruiting)
• CHU de Nancy - Hôpital Central — Nancy, France (Terminated)
• CHU de Nantes Hôpital Laennec — Nantes, France (Active_not_recruiting)
• GHU Paris Psychiatrie & Neurosciences — Paris, France (Completed)
• Fondation Ophtalmologique Adolphe de Rothschild — Paris, France (Recruiting)
• Hôpital de la Pitié Salpétrière — Paris, France (Recruiting)
• CHU Reims Hôpital Maison Blanche — Reims, France (Withdrawn)
• CHU Hôpitaux de Rouen - Hôpital Charles Nicolle — Rouen, France (Recruiting)
• CHU Toulouse - Hôpital Pierre-Paul Riquet — Toulouse, France (Recruiting)
• CHRU de Tours - Hôpital Brettoneau — Tours, France (Recruiting)
• Centre Hospitalier Bretagne Atlantique Vannes - Auray — Vannes, France (Completed)
• Klinikum Augsburg — Augsburg, Germany (Withdrawn)
• Charité Universitätsmedizin Berlin -Campus Charite — Berlin, Germany (Completed)
• Knappschaftskrankenhaus Bochum-Langendreer - Universitätsklinik — Bochum, Germany (Suspended)
• HELIOS Klinikum Erfurt — Erfurt, Germany (Withdrawn)

Study contacts

• Study coordinator: Wouter Fabry

Conditions Intracranial Aneurysm; Stroke, Ischemic; Embolization Device; Flow Diverter; Intrasaccular device; Vascular Reconstruction Device; Ruptured Intracranial Aneurysm; Unruptured Intracranial Aneurysm