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Clinical Trial NCT02988128 (INSPIRE) for Intracranial Aneurysm, Stroke, Ischemic is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Neurovascular Product Surveillance Registry (INSPIRE)

Recruiting
Clinical Trial NCT02988128 (INSPIRE) is an observational study for Intracranial Aneurysm, Stroke, Ischemic that is recruiting. It started on 1 December 2016 with plans to enroll 4,000 participants. Led by Medtronic Neurovascular Clinical Affairs, it is expected to complete by 1 August 2032. The latest data from ClinicalTrials.gov was last updated on 21 November 2025.
Brief Summary
Post market surveillance registry
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).

Official Title

NeuroVascular Product Surveillance Registry (PSR) Platform

Conditions
Intracranial AneurysmStroke, Ischemic
Other Study IDs
  • INSPIRE
  • MDT16056/17077/24028/22032
NCT ID Number
Start Date (Actual)
2016-12
Last Update Posted
2025-11-21
Completion Date (Estimated)
2032-08
Enrollment (Estimated)
4,000
Study Type
Observational
Status
Recruiting
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
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Intracranial aneurysm
Patients undergoing treatment for intracranial aneurysms (IA) with Medtronic market approved device(s).
Treatment for Intracranial Aneurysms
Embolization of aneurysms
Acute Ischemic Stroke
Patients undergoing treatment for acute ischemic stroke (AIS) with Medtronic market approved device(s).
Treatment for Acute Ischemic Stroke
Revascularization of an intracranial blood vessel
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
For MDT16056 and MDT17077
  • 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.

  • 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.

Medtronic Neurovascular Clinical Affairs logoMedtronic Neurovascular Clinical Affairs
Medtronic Cardiac Rhythm and Heart Failure logoMedtronic Cardiac Rhythm and Heart Failure
Study Central Contact
Contact: Wouter Fabry, +32496165078, [email protected]
Contact: Beatrice Carlotta Sicurella, +390224137264, [email protected]
99 Study Locations in 24 Countries
Prince of Wales Hospital, Hong Kong, Hong Kong
Active, not recruiting
The University of Hong Kong, Hong Kong, Hong Kong
Completed
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
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
Recruiting
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
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
Active, not recruiting
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