Neurovascular Product Surveillance Registry (INSPIRE)
May 31, 2026 updated by: Medtronic Neurovascular Clinical Affairs
NeuroVascular Product Surveillance Registry (PSR) Platform
Post market surveillance registry
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Observational
Enrollment (Estimated)
4000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Wouter Fabry
- Phone Number: +32496165078
- Email: wouter.fabry@medtronic.com
Study Contact Backup
- Name: Beatrice Carlotta Sicurella
- Phone Number: +390224137264
- Email: beatrice.carlotta.sicurella@medtronic.com
Study Locations
-
-
-
Buenos Aires, Argentina
- Recruiting
- ENERI
-
-
-
-
-
Southport, Australia
- Active, not recruiting
- Gold Coast University Hospital
-
-
-
-
-
Salzburg, Austria, 5020
- Recruiting
- Universitätsklinikum Christian Doppler Klinik Salzburg
-
-
-
-
-
Genk, Belgium
- Completed
- Ziekenhuis Oost Limburg - Campus Sint-Jan
-
Ghent, Belgium
- Completed
- Universitair Ziekenhuis Gent
-
-
-
-
-
Beijing, China, 100053
- Completed
- Xuanwu Hospital Capital Medical University
-
Chongqing, China, 404000
- Completed
- Chongqing University Three Gorges Hospital
-
Jiamusi, China, 154000
- Terminated
- First Affiliated Hospital of Jiamusi University
-
Ji’an, China, 343600
- Completed
- The Affiliated Hospital of Jinggangshan University
-
Kaifeng, China, 475000
- Terminated
- Kaifeng Central Hospital
-
Liaocheng, China, 252001
- Terminated
- Liaocheng People's Hospital
-
Lishui, China, 323020
- Terminated
- Lishui Municipal Central Hospital
-
Nanchang, China, 330006
- Terminated
- The Second Affiliated Hospital of Nanchang University
-
Nanning, China, 530031
- Completed
- The Second Nanning Peoples Hospital
-
Panzhihua, China, 617067
- Terminated
- Panzhihua Central Hospital
-
Qujing, China, 655000
- Terminated
- Qujing First Peoples Hospital
-
Shanghai, China, 200082
- Completed
- Yangpu District Central Hospital Shanghai Yangpu Hospital Tongji University
-
Taiyuan, China, 30024
- Completed
- Shanxi Cardiovascular Hospital
-
Xi'an, China, 710061
- Completed
- The First Affiliated Hospital of Xi'an Jiaotong University
-
Xianyang, China, 712000
- Completed
- The First Peoples Hospital of Xianyang
-
Zhangzhou, China, 363000
- Completed
- Zhangzhou Municipal Hospital of Fujian Province
-
Zhuhai, China, 519070
- Terminated
- Zhuhai Peoples Hospital
-
Zhumadian, China, 463000
- Completed
- Zhumadian Central Hospital
-
-
-
-
-
Copenhagen, Denmark
- Recruiting
- Rigshospitalet
-
-
-
-
-
Turku, Finland
- Recruiting
- Turun yliopistollinen keskussairaala
-
-
-
-
-
Besançon, France
- Active, not recruiting
- CHU Besançon - Hôpital Jean Minjoz
-
Bordeaux, France, 33000
- Completed
- CHU de Bordeaux - Centre Universitaire Pellegrin
-
Brest, France
- Recruiting
- CHU Brest, Hôpital de la Cavale Blanche
-
Bron, France
- Recruiting
- Hopital Pierre Wertheimer
-
Caen, France
- Completed
- CHU de Caen
-
Clermont-Ferrand, France, 63003
- Completed
- Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
-
Dijon, France, 21079
- Completed
- CHU Dijon Bourgogne
-
Le Kremlin-Bicêtre, France
- Recruiting
- AP-HP Hopital Bicetre
-
Limoges, France
- Recruiting
- CHU Limoges - Hopital Dupuytren
-
Marseille, France
- Recruiting
- Hôpital de la Timone-CHU de Marseille
-
Montpellier, France
- Recruiting
- CHU de Montpellier - Hôpital Gui de Chauliac
-
Nancy, France, 54035
- Terminated
- CHU de Nancy - Hôpital Central
-
Nantes, France
- Active, not recruiting
- CHU de Nantes Hôpital Laennec
-
Paris, France
- Recruiting
- Fondation Ophtalmologique Adolphe de Rothschild
-
Paris, France
- Recruiting
- Hôpital de la Pitié Salpêtrière
-
Paris, France, 75014
- Completed
- GHU Paris Psychiatrie & Neurosciences
-
Reims, France
- Withdrawn
- CHU Reims Hôpital Maison Blanche
-
Rouen, France
- Recruiting
- CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
-
Toulouse, France
- Recruiting
- CHU Toulouse - Hôpital Pierre-Paul Riquet
-
Tours, France, 37000
- Recruiting
- CHRU de Tours - Hôpital Brettoneau
-
Vannes, France, 56000
- Completed
- Centre Hospitalier Bretagne Atlantique Vannes - Auray
-
-
-
-
-
Augsburg, Germany
- Withdrawn
- Klinikum Augsburg
-
Berlin, Germany
- Completed
- Charité Universitätsmedizin Berlin -Campus Charite
-
Bochum, Germany, 44892
- Suspended
- Knappschaftskrankenhaus Bochum-Langendreer - Universitätsklinik
-
Erfurt, Germany
- Withdrawn
- Helios Klinikum Erfurt
-
Erlangen, Germany
- Suspended
- Universitätsklinikum Erlangen
-
Essen, Germany
- Completed
- Alfried Krupp Krankenhaus
-
Freiburg im Breisgau, Germany, 79065
- Recruiting
- Universitätsklinikum Freiburg
-
Hamburg, Germany
- Withdrawn
- Universitätsklinikum Hamburg-Eppendorf
-
Heidelberg, Germany
- Recruiting
- Universitatsklinikum Heidelberg
-
Munich, Germany, 80336
- Recruiting
- LMU Klinikum der Universität München
-
Nuremberg, Germany, 90471
- Recruiting
- Klinikum Nürnberg - Klinikum Nürnberg Süd
-
-
-
-
-
Athens, Greece
- Recruiting
- Hellenic Airforce 251 General Hospital
-
-
-
-
-
Hong Kong, Hong Kong
- Active, not recruiting
- Prince of Wales Hospital
-
Hong Kong, Hong Kong
- Completed
- The University of Hong Kong
-
-
-
-
-
Budapest, Hungary
- Recruiting
- Orszagos Klinikai Idegtudomanyi Intezet
-
-
-
-
-
Jerusalem, Israel
- Terminated
- Hadassah Medical Organization
-
Ramat Gan, Israel
- Recruiting
- Sheba Medical Center
-
-
-
-
-
Florence, Italy
- Completed
- Azienda Ospedaliero-Universitaria Careggi
-
Milan, Italy, 20133
- Active, not recruiting
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
-
Milan, Italy
- Recruiting
- Azienda Ospedaliera Ospedale Niguarda Ca Granda
-
-
-
-
-
Warsaw, Poland, 04-141
- Completed
- Military Medical Institute-Wojskowy Instytut Medyczny
-
-
-
-
-
Vila Nova de Gaia, Portugal, 4434-502
- Completed
- Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
-
-
-
-
-
Novosibirsk, Russia
- Completed
- Siberian Federal Biomedical Research Center
-
Saint Petersburg, Russia
- Completed
- Almazov National Medical Research Centre
-
-
-
-
-
Bratislava, Slovakia
- Recruiting
- CINRE s.r.o.
-
-
-
-
-
Johannesburg, South Africa
- Withdrawn
- Chris Hani Baragwaneth Hospital
-
-
-
-
-
Daejeon, South Korea, 301-721
- Completed
- Chungnam National University Hospital
-
Gwangju, South Korea, 102-602
- Completed
- Chonnam National University Hospital
-
Gwangju, South Korea, 61453
- Completed
- Chosun University Hospital
-
Jeonju, South Korea, 54907
- Completed
- Jeonbuk National University Hospital
-
Seoul, South Korea, 03722
- Withdrawn
- Severance Hospital
-
Seoul, South Korea, 06351
- Completed
- Samsung Medical Center
-
Seoul, South Korea, 138-736
- Completed
- Asan Medical Center
-
Suwon, South Korea, 16499
- Completed
- Ajou University Medical Center
-
Ulsan, South Korea, 44033
- Completed
- Ulsan University Hospital
-
-
-
-
-
Barakaldo, Spain
- Completed
- Hospital de Cruces
-
Barcelona, Spain
- Recruiting
- Hospital Vall d'Hebron
-
Madrid, Spain
- Withdrawn
- Hospital Fundacion Jimenez Diaz
-
Madrid, Spain
- Completed
- Hospital Universitario de La Paz
-
Oviedo, Spain
- Recruiting
- Hospital Universitario Central de Asturias
-
San Sebastián, Spain
- Recruiting
- Hospital Universitario Donostia
-
Seville, Spain, 41013
- Completed
- Hospital Universitario Virgen del Rocio
-
Valladolid, Spain
- Recruiting
- Hospital Clínico Universitario de Valladolid
-
Vigo, Spain, 36312
- Recruiting
- Hospital Alvaro Cunqueiro
-
-
-
-
-
Basel, Switzerland, 4031
- Recruiting
- Universitätsspital Basel
-
Bern, Switzerland
- Completed
- INSELSPITAL - Universitätsspital Bern
-
Geneva, Switzerland
- Completed
- Hôpitaux Universitaires de Genève
-
-
-
-
-
Abu Dhabi, United Arab Emirates
- Recruiting
- Cleveland Clinic - Abu Dhabi
-
-
-
-
-
Birmingham, United Kingdom
- Recruiting
- University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
-
Edinburgh, United Kingdom, EH16 4SA
- Recruiting
- Royal Infirmary of Edinburgh
-
London, United Kingdom, W6 8RF
- Recruiting
- Imperial College Healthcare NHS Trust - Charing Cross Hospital
-
Romford, United Kingdom
- Recruiting
- Barking, Havering and Redbridge University Hospitals - Queen's Hospital
-
Stoke-on-Trent, United Kingdom, ST4 6QG
- Recruiting
- University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intracranial aneurysm
Patients undergoing treatment for intracranial aneurysms (IA) with Medtronic market approved device(s).
|
Embolization of aneurysms
|
|
Acute Ischemic Stroke
Patients undergoing treatment for acute ischemic stroke (AIS) with Medtronic market approved device(s).
|
Revascularization of an intracranial blood vessel
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
Time Frame: 1 year
|
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
Time Frame: 90 days
|
For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2
|
90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Markus Holtmannspotter, MD, Klinikum Nurnberg Sud
- 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, Hopital 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 record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Estimated)
August 1, 2032
Study Completion (Estimated)
August 1, 2032
Study Registration Dates
First Submitted
December 7, 2016
First Submitted That Met QC Criteria
December 7, 2016
First Posted (Estimated)
December 9, 2016
Study Record Updates
Last Update Posted (Actual)
June 2, 2026
Last Update Submitted That Met QC Criteria
May 31, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MDT16056/17077/24028/22032
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Only multi center data will be available
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.