Neurovascular Product Surveillance Registry

Last updated: May 8, 2025
Sponsor: Medtronic Neurovascular Clinical Affairs
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aneurysm

Stroke

Cardiac Ischemia

Treatment

Treatment for Acute Ischemic Stroke

Treatment for intracranial aneurysms

Clinical Study ID

NCT02988128
MDT16056/17077/24028/22032
  • Ages > 18
  • All Genders

Study Summary

Post market surveillance registry

Eligibility Criteria

Inclusion

For MDT16056 and MDT17077

Inclusion Criteria:

  • Patient or legally authorized representative (LAR) provides authorization and/orconsent per institution and geographical requirements

  • Patient has, or is intended to receive or be treated with, an eligible Medtronicproduct

  • Patient is consented within the enrollment window of the therapy received, asapplicable

  • Patient is at least 18 years of age at time of enrollment.

Exclusion

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/ordevice study that may confound results

  • Female patient who is known to be pregnant or is breastfeeding or wishes to becomepregnant during participation in the study.

For MDT24028 and MDT22032:

General Inclusion Criteria:

  • Patient or legally authorized representative (LAR) provides authorization and/orconsent per institution and geographical requirements.

  • Patient is treated or intended to be treated with an eligible MedtronicNeurovascular product.

  • Patient is an adult per local law at time of consent. Medtronic Business RestrictedThis document is electronically controlled CONFIDENTIAL 056-F275 Rev F ClinicalInvestigation 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 becomepregnant during participation in the study

  • Patient is currently enrolled in, or plans to enroll in, any concurrent drug/devicestudy that may confound the study results.

Additional criteria may be required, refer to cohort-specific Addendum, as applicable, for further guidance.

Study Design

Total Participants: 4000
Treatment Group(s): 2
Primary Treatment: Treatment for Acute Ischemic Stroke
Phase:
Study Start date:
December 01, 2016
Estimated Completion Date:
August 31, 2032

Study 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).

Connect with a study center

  • ENERI

    Buenos Aires,
    Argentina

    Completed

  • Gold Coast University Hospital

    Southport,
    Australia

    Site Not Available

  • Universitätsklinikum Christian Doppler Klinik Salzburg

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Ziekenhuis Oost Limburg - Campus Sint-Jan

    Genk,
    Belgium

    Completed

  • Universitair Ziekenhuis Gent

    Gent,
    Belgium

    Completed

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053
    China

    Completed

  • Chongqing University Three Gorges Hospital

    Chongqing, 404000
    China

    Completed

  • The Affiliated Hospital of Jinggangshan University

    Ji'an, 343600
    China

    Completed

  • First Affiliated Hospital of Jiamusi University

    Jiamusi, 154000
    China

    Terminated

  • Kaifeng Central Hospital

    Kaifeng, 475000
    China

    Terminated

  • Liaocheng People's Hospital

    Liaocheng, 252001
    China

    Terminated

  • Lishui Municipal Central Hospital

    Lishui, 323020
    China

    Terminated

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330006
    China

    Terminated

  • The Second Nanning Peoples Hospital

    Nanning, 530031
    China

    Completed

  • Panzhihua Central Hospital

    Panzhihua, 617067
    China

    Terminated

  • Qujing First Peoples Hospital

    Qujing, 655000
    China

    Terminated

  • Yangpu District Central Hospital Shanghai Yangpu Hospital Tongji University

    Shanghai, 200082
    China

    Completed

  • Shanxi Cardiovascular Hospital

    Taiyuan, 30024
    China

    Completed

  • The First Affiliated Hospital Of Xi'an Jiaotong University

    Xi'an, 710061
    China

    Completed

  • The First Peoples Hospital of Xianyang

    Xianyang, 712000
    China

    Completed

  • Zhangzhou Municipal Hospital of Fujian Province

    Zhangzhou, 363000
    China

    Completed

  • Zhuhai Peoples Hospital

    Zhuhai, 519070
    China

    Terminated

  • Zhumadian Central Hospital

    Zhumadian, 463000
    China

    Completed

  • Rigshospitalet

    Copenhagen,
    Denmark

    Active - Recruiting

  • Turun Yliopistollinen keskussairaala

    Turku,
    Finland

    Active - Recruiting

  • CHU Besancon - Hôpital Jean Minjoz

    Besançon,
    France

    Active - Recruiting

  • CHU de Bordeaux - Centre Universitaire Pellegrin

    Bordeaux, 33000
    France

    Site Not Available

  • CHU Brest, Hôpital de la Cavale Blanche

    Brest,
    France

    Active - Recruiting

  • Hôpital Pierre Wertheimer

    Bron,
    France

    Active - Recruiting

  • CHU de Caen

    Caen,
    France

    Completed

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

    Clermont-Ferrand, 63003
    France

    Completed

  • CHU Dijon Bourgogne

    Dijon, 21079
    France

    Site Not Available

  • AP-HP Hôpital Bicêtre

    Le Kremlin-Bicêtre,
    France

    Active - Recruiting

  • CHU Limoges - Hôpital Dupuytren

    Limoges,
    France

    Active - Recruiting

  • Hôpital de la Timone-CHU de Marseille

    Marseille,
    France

    Active - Recruiting

  • CHU de Montpellier - Hôpital Gui de Chauliac

    Montpellier,
    France

    Active - Recruiting

  • CHU de Nancy - Hôpital Central

    Nancy, 54035
    France

    Terminated

  • CHU de Nantes Hôpital Laennec

    Nantes,
    France

    Site Not Available

  • Fondation Ophtalmologique Adolphe de Rothschild

    Paris,
    France

    Active - Recruiting

  • GHU Paris Psychiatrie & Neurosciences

    Paris, 75014
    France

    Completed

  • Hôpital de la Pitié Salpétrière

    Paris,
    France

    Active - Recruiting

  • CHU Reims Hôpital Maison Blanche

    Reims,
    France

    Site Not Available

  • CHU Hôpitaux de Rouen - Hôpital Charles Nicolle

    Rouen,
    France

    Active - Recruiting

  • CHU Toulouse - Hôpital Pierre-Paul Riquet

    Toulouse,
    France

    Active - Recruiting

  • CHRU de Tours - Hôpital Brettoneau

    Tours, 37000
    France

    Active - Recruiting

  • Centre Hospitalier Bretagne Atlantique Vannes - Auray

    Vannes, 56000
    France

    Completed

  • Klinikum Augsburg

    Augsburg,
    Germany

    Site Not Available

  • Charité Universitätsmedizin Berlin -Campus Charite

    Berlin,
    Germany

    Completed

  • Knappschaftskrankenhaus Bochum-Langendreer - Universitätsklinik

    Bochum, 44892
    Germany

    Active - Recruiting

  • HELIOS Klinikum Erfurt

    Erfurt,
    Germany

    Site Not Available

  • Universitätsklinikum Erlangen

    Erlangen,
    Germany

    Suspended

  • Alfried Krupp Krankenhaus

    Essen,
    Germany

    Completed

  • Universitätsklinikum Freiburg

    Freiburg, 79065
    Germany

    Active - Recruiting

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg,
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg,
    Germany

    Active - Recruiting

  • LMU Klinikum der Universität München

    Munich, 80336
    Germany

    Active - Recruiting

  • Klinikum Nürnberg - Klinikum Nürnberg Süd

    Nürnberg, 90471
    Germany

    Active - Recruiting

  • Hellenic Airforce 251 General Hospital

    Athen,
    Greece

    Active - Recruiting

  • Prince of Wales Hospital

    Hong Kong,
    Hong Kong

    Site Not Available

  • The University of Hong Kong

    Hong Kong,
    Hong Kong

    Completed

  • Országos Klinikai Idegtudományi Intézet

    Budapest,
    Hungary

    Active - Recruiting

  • Hadassah Medical Organization

    Jerusalem,
    Israel

    Terminated

  • Sheba Medical Center

    Ramat Gan,
    Israel

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Careggi

    Firenze,
    Italy

    Site Not Available

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

    Milan, 20133
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedale Niguarda Cà Granda

    Milano,
    Italy

    Active - Recruiting

  • Chungnam National University Hospital

    Daejeon, 301-721
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hospital

    Gwangju, 102-602
    Korea, Republic of

    Site Not Available

  • Chosun University Hospital

    Gwangju, 61453
    Korea, Republic of

    Completed

  • Jeonbuk National University Hospital

    Jeonju, 54907
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 138-736
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Severance Hospital

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • Ajou University Medical Center

    Suwon, 16499
    Korea, Republic of

    Active - Recruiting

  • Ulsan University Hospital

    Ulsan, 44033
    Korea, Republic of

    Active - Recruiting

  • Military Medical Institute-Wojskowy Instytut Medyczny

    Warszawa, 04-141
    Poland

    Completed

  • Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I

    Vila Nova de Gaia, 4434-502
    Portugal

    Completed

  • Siberian Federal Biomedical Research Center

    Novosibirsk,
    Russian Federation

    Completed

  • Almazov National Medical Research Centre

    St. Petersburg,
    Russian Federation

    Completed

  • CINRE s.r.o.

    Bratislava,
    Slovakia

    Active - Recruiting

  • Chris Hani Baragwaneth Hospital

    Johannesburg,
    South Africa

    Site Not Available

  • Hospital De Cruces

    Barakaldo,
    Spain

    Completed

  • Hospital Vall D'Hebron

    Barcelona,
    Spain

    Active - Recruiting

  • Hospital Fundación Jiménez Díaz

    Madrid,
    Spain

    Site Not Available

  • Hospital Universitario de La Paz

    Madrid,
    Spain

    Completed

  • Hospital Universitario Central de Asturias

    Oviedo,
    Spain

    Site Not Available

  • Hospital Universitario Donostia

    San Sebastián,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Completed

  • Hospital Clínico Universitario de Valladolid

    Valladolid,
    Spain

    Active - Recruiting

  • Hospital Álvaro Cunqueiro

    Vigo, 36312
    Spain

    Active - Recruiting

  • Universitätsspital Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • Inselspital - Universitätsspital Bern

    Bern,
    Switzerland

    Completed

  • Hôpitaux Universitaires de Genève

    Geneve,
    Switzerland

    Completed

  • Cleveland Clinic - Abu Dhabi

    Abu Dhabi,
    United Arab Emirates

    Active - Recruiting

  • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

    Birmingham,
    United Kingdom

    Active - Recruiting

  • Imperial College Healthcare NHS Trust - Charing Cross Hospital

    London, W6 8RF
    United Kingdom

    Active - Recruiting

  • Barking, Havering and Redbridge University Hospitals - Queen's Hospital

    Romford,
    United Kingdom

    Active - Recruiting

  • University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital

    Stoke on Trent, ST4 6QG
    United Kingdom

    Completed

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