Neurovascular Product Surveillance Registry

NCT02988128 | Recruiting FDA Device

• 1 other identifier: MDT16056/17077/24028/22032
• Study Type: observational
• Target: 4,000
• Locations: 23 countries
• Sites: 98

Brief Summary

Post market surveillance registry

Conditions

Stroke, Ischemic; Intracranial Aneurysm

Keywords

Embolization Device; Flow Diverter; Intrasaccular device; Vascular Reconstruction Device; Ruptured Intracranial Aneurysm; Unruptured Intracranial Aneurysm; Large Vessel Occlusion; Stent Retriever; Aspiration Catheter; Revascularization Device

Outcome Measures

Primary Outcomes (2)

• The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).

  For Intracranial Aneurysm the primary outcome is the clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).

  1 year

• Functional Independence: mRS score ≤ 2

  For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2

  90 days

Study Arms (2)

Intracranial aneurysm

Patients undergoing treatment for intracranial aneurysms (IA) with Medtronic market approved device(s).

Device: Treatment for intracranial aneurysms

Acute Ischemic Stroke

Patients undergoing treatment for acute ischemic stroke (AIS) with Medtronic market approved device(s).

Device: Treatment for Acute Ischemic Stroke

Interventions

Treatment for intracranial aneurysms DEVICE

Embolization of aneurysms

Intracranial aneurysm

Treatment for Acute Ischemic Stroke DEVICE

Revascularization of an intracranial blood vessel

Acute Ischemic Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intracranial aneurysms: Patients requiring treatment for intracranial aneurysms with Medtronic market-approved flow diverters, intrasaccular devices, vascular reconstruction devices and/or ancillary devices are eligible for the registry. Acute Ischemic Stroke: Patients requiring treatment with Medtronic market approved stent retrievers and/or aspiration devices, and/or ancillary devices for the treatment of acute ischemic stroke due to intracranial vessel occlusion are eligible for enrollment in the registry.

You may qualify if:

• 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.

You may not qualify if:

• 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 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
• 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.

Sponsors & Collaborators

• Medtronic Neurovascular Clinical Affairs: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (99)

ENERI

Buenos Aires, Argentina

COMPLETED

Gold Coast University Hospital

Southport, Australia

ACTIVE NOT RECRUITING

Universitätsklinikum Christian Doppler Klinik Salzburg

Salzburg, 5020, Austria

RECRUITING

Ziekenhuis Oost Limburg - Campus Sint-Jan

Genk, Belgium

COMPLETED

Universitair Ziekenhuis Gent

Ghent, Belgium

COMPLETED

Xuanwu Hospital Capital Medical University

Beijing, 100053, China

COMPLETED

Chongqing University Three Gorges Hospital

Chongqing, 404000, China

COMPLETED

First Affiliated Hospital of Jiamusi University

Jiamusi, 154000, China

TERMINATED

The Affiliated Hospital of Jinggangshan University

Ji’an, 343600, China

COMPLETED

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

RECRUITING

Turun Yliopistollinen keskussairaala

Turku, Finland

RECRUITING

CHU Besancon - Hôpital Jean Minjoz

Besançon, France

ACTIVE NOT RECRUITING

CHU de Bordeaux - Centre Universitaire Pellegrin

Bordeaux, 33000, 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, 63003, France

COMPLETED

CHU Dijon Bourgogne

Dijon, 21079, 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, 54035, France

TERMINATED

CHU de Nantes Hôpital Laennec

Nantes, France

ACTIVE NOT RECRUITING

GHU Paris Psychiatrie & Neurosciences

Paris, 75014, 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, 37000, France

RECRUITING

Centre Hospitalier Bretagne Atlantique Vannes - Auray

Vannes, 56000, France

COMPLETED

Klinikum Augsburg

Augsburg, Germany

WITHDRAWN

Charité Universitätsmedizin Berlin -Campus Charite

Berlin, Germany

COMPLETED

Knappschaftskrankenhaus Bochum-Langendreer - Universitätsklinik

Bochum, 44892, Germany

SUSPENDED

HELIOS Klinikum Erfurt

Erfurt, Germany

WITHDRAWN

Universitätsklinikum Erlangen

Erlangen, Germany

SUSPENDED

Alfried Krupp Krankenhaus

Essen, Germany

COMPLETED

Universitätsklinikum Freiburg

Freiburg im Breisgau, 79065, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

WITHDRAWN

Universitätsklinikum Heidelberg

Heidelberg, Germany

RECRUITING

LMU Klinikum der Universität München

Munich, 80336, Germany

RECRUITING

Klinikum Nürnberg - Klinikum Nürnberg Süd

Nuremberg, 90471, Germany

RECRUITING

Hellenic Airforce 251 General Hospital

Athens, Greece

RECRUITING

Prince of Wales Hospital

Hong Kong, Hong Kong

ACTIVE NOT RECRUITING

The University of Hong Kong

Hong Kong, Hong Kong

COMPLETED

Országos Klinikai Idegtudományi Intézet

Budapest, Hungary

RECRUITING

Hadassah Medical Organization

Jerusalem, Israel

TERMINATED

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

COMPLETED

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

Milan, 20133, Italy

ACTIVE NOT RECRUITING

Azienda Ospedaliera Ospedale Niguarda Cà Granda

Milan, Italy

RECRUITING

Military Medical Institute-Wojskowy Instytut Medyczny

Warsaw, 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, Russia

COMPLETED

Almazov National Medical Research Centre

Saint Petersburg, Russia

COMPLETED

CINRE s.r.o.

Bratislava, Slovakia

RECRUITING

Chris Hani Baragwaneth Hospital

Johannesburg, South Africa

WITHDRAWN

Chungnam National University Hospital

Daejeon, 301-721, South Korea

COMPLETED

Chonnam National University Hospital

Gwangju, 102-602, South Korea

COMPLETED

Chosun University Hospital

Gwangju, 61453, South Korea

COMPLETED

Jeonbuk National University Hospital

Jeonju, 54907, South Korea

COMPLETED

Severance Hospital

Seoul, 03722, South Korea

WITHDRAWN

Samsung Medical Center

Seoul, 06351, South Korea

COMPLETED

Asan Medical Center

Seoul, 138-736, South Korea

COMPLETED

Ajou University Medical Center

Suwon, 16499, South Korea

COMPLETED

Ulsan University Hospital

Ulsan, 44033, South Korea

COMPLETED

Hospital De Cruces

Barakaldo, Spain

COMPLETED

Hospital Vall D'Hebron

Barcelona, Spain

RECRUITING

Hospital Fundación Jiménez Díaz

Madrid, Spain

WITHDRAWN

Hospital Universitario de La Paz

Madrid, Spain

COMPLETED

Hospital Universitario Central de Asturias

Oviedo, Spain

RECRUITING

Hospital Universitario Donostia

San Sebastián, Spain

RECRUITING

Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

COMPLETED

Hospital Clínico Universitario de Valladolid

Valladolid, Spain

RECRUITING

Hospital Álvaro Cunqueiro

Vigo, 36312, Spain

RECRUITING

Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

Inselspital - Universitätsspital Bern

Bern, Switzerland

COMPLETED

Hôpitaux Universitaires de Genève

Geneva, Switzerland

COMPLETED

Cleveland Clinic - Abu Dhabi

Abu Dhabi, United Arab Emirates

RECRUITING

University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

Birmingham, United Kingdom

RECRUITING

Royal Infirmary of Edinburgh

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust - Charing Cross Hospital

London, W6 8RF, United Kingdom

RECRUITING

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

Romford, United Kingdom

RECRUITING

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

Stoke-on-Trent, ST4 6QG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm; Ischemic Stroke

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Stroke

Study Officials

• Markus Holtmannspotter, MD

  Klinikum Nürnberg Süd

  STUDY CHAIR

• Laurent Spelle, MD

  Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et Pédiatrique

  STUDY CHAIR

• Jens Fiehler, MD

  Universitätsklinikum Hamburg-Eppendorf

  STUDY CHAIR

• István Szikora, MD

  National Institute of Clinical Neurosciences

  STUDY CHAIR

• Mario Galdamez, MD

  Hospital Clínico Universitario de Valladolid

  STUDY CHAIR

• Saleh Lamin, MD

  Queen Elisabeth Hospital, Neuroradiology

  STUDY CHAIR

• Francis Turjman, MD

  Hôpital Pierre Wertheimer

  STUDY CHAIR

• Christophe Cognard, MD

  CHU Toulouse - Hôpital Purpan

  STUDY CHAIR

• Markus Möhlenbruch, MD

  University Hospital Heidelberg

  STUDY CHAIR

• Marc Ribó, MD

  Hospital Vall d'Hebron

  STUDY CHAIR

• Pasquale Mordasini, MD

  Inselspital - Universitätsspital Bern

  STUDY CHAIR

• Sanjeev Nayak, MD

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

  STUDY CHAIR

• Riitta Rautio, MD

  Turun Yliopistollinen keskussairaala

  STUDY CHAIR

• Monika Killer-Oberpfalzer, MD

  Universitätsklinikum Christian Doppler Klinik Salzburg

  STUDY CHAIR

Central Study Contacts

Wouter Fabry

CONTACT

+32496165078; wouter.fabry@medtronic.com

Beatrice Carlotta Sicurella

CONTACT

+390224137264; beatrice.carlotta.sicurella@medtronic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 9, 2016
• Study Start: December 1, 2016
• Primary Completion (Estimated): August 1, 2032
• Study Completion (Estimated): August 1, 2032
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (9); RU (2); GR (1); PL (1); DK (1); CN (18); ZA (1); HK (2); FI (1); IL (2); BE (2); PT (1); GB (5); FR (21); HU (1); ES (9); SL (1); AU (1); DE (11); AE (1); CH (3); AR (1); IT (3)