Neurovascular Product Surveillance Registry (INSPIRE)

April 11, 2024 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.

This study is conducted under the Product Surveillance Registry (NCT01524276).

Study Type

Observational

Enrollment (Estimated)

3000

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

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Active, not recruiting
        • ENERI
  • Australia
      • Southport, Australia
        • Active, not recruiting
        • Gold Coast University Hospital
  • Austria
      • Salzburg, Austria, 5020
        • Recruiting
        • Universitätsklinikum Christian Doppler Klinik Salzburg
  • Belgium
      • Genk, Belgium
        • Active, not recruiting
        • Ziekenhuis Oost Limburg - Campus Sint-Jan
      • Gent, Belgium
        • Active, not recruiting
        • Universitair Ziekenhuis Gent
  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital Capital Medical University
      • Chongqing, China, 404000
        • Recruiting
        • Chongqing University Three Gorges Hospital
      • Ji'an, China, 343600
        • Recruiting
        • The Affiliated Hospital of Jinggangshan University
      • Jiamusi, China, 154000
        • Recruiting
        • First Affiliated Hospital of Jiamusi University
      • Kaifeng, China, 475000
        • Recruiting
        • Kaifeng Central Hospital
      • Liaocheng, China, 252001
        • Recruiting
        • Liaocheng People's Hospital
      • Lishui, China, 323020
        • Active, not recruiting
        • Lishui Municipal Central Hospital
      • Nanchang, China, 330006
        • Active, not recruiting
        • The Second Affiliated Hospital of Nanchang University
      • Nanning, China, 530031
        • Recruiting
        • The Second Nanning Peoples Hospital
      • Panzhihua, China, 617067
        • Terminated
        • Panzhihua Central Hospital
      • Qujing, China, 655000
        • Terminated
        • Qujing First Peoples Hospital
      • Shanghai, China, 200082
        • Recruiting
        • Yangpu District Central Hospital Shanghai Yangpu Hospital Tongji University
      • Taiyuan, China, 30024
        • Recruiting
        • Shanxi Cardiovascular Hospital
      • Xi'an, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University
      • Xianyang, China, 712000
        • Recruiting
        • The First Peoples Hospital of Xianyang
      • Zhangzhou, China, 363000
        • Recruiting
        • Zhangzhou Municipal Hospital of Fujian Province
      • Zhuhai, China, 519070
        • Active, not recruiting
        • Zhuhai Peoples Hospital
      • Zhumadian, China, 463000
        • Recruiting
        • Zhumadian Central Hospital
  • Denmark
      • Copenhagen, Denmark
        • Active, not recruiting
        • Rigshospitalet
  • Finland
      • Turku, Finland
        • Recruiting
        • Turun yliopistollinen keskussairaala
  • France
      • Besançon, France
        • Recruiting
        • CHU Besançon - Hôpital Jean Minjoz
      • Bordeaux, France, 33000
        • Recruiting
        • CHU de Bordeaux - Centre Universitaire Pellegrin
      • Brest, France
        • Recruiting
        • CHU Brest, Hôpital de la Cavale Blanche
      • Bron, France
        • Recruiting
        • Hopital Pierre Wertheimer
      • Caen, France
        • Active, not recruiting
        • CHU de Caen
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
      • Dijon, France, 21079
        • Recruiting
        • CHU Dijon Bourgogne
      • Le Kremlin-Bicêtre, France
        • Recruiting
        • AP-HP Hopital Bicetre
      • Limoges, France
        • Recruiting
        • CHU Limoges - Hôpital Dupuytren
      • Marseille, France
        • Recruiting
        • Hôpital de la Timone-CHU de Marseille
      • Montpellier, France
        • Recruiting
        • CHU de Montpellier - Hôpital Gui de Chauliac
      • Nancy, France, 54035
        • Withdrawn
        • 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, 75014
        • Recruiting
        • GHU Paris Psychiatrie & Neurosciences
      • Paris, France
        • Recruiting
        • Hopital de la Pitie Salpetriere
      • 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
        • Recruiting
        • Centre Hospitalier Bretagne Atlantique Vannes - Auray
  • Germany
      • Augsburg, Germany
        • Withdrawn
        • Klinikum Augsburg
      • Berlin, Germany
        • Active, not recruiting
        • Charité Universitätsmedizin Berlin -Campus Charite
      • Bochum, Germany, 44892
        • Recruiting
        • Knappschaftskrankenhaus Bochum-Langendreer - Universitätsklinik
      • Erfurt, Germany
        • Withdrawn
        • Helios Klinikum Erfurt
      • Erlangen, Germany
        • Active, not recruiting
        • Universitätsklinikum Erlangen
      • Essen, Germany
        • Active, not recruiting
        • Alfried Krupp Krankenhaus
      • Freiburg, Germany, 79065
        • Active, not recruiting
        • Universitätsklinikum Freiburg
      • Hamburg, Germany
        • Withdrawn
        • Universitätsklinikum Hamburg-Eppendorf
      • Heidelberg, Germany
        • Recruiting
        • Universitätsklinikum Heidelberg
      • Munich, Germany, 80336
        • Recruiting
        • LMU Klinikum der Universität München
      • Nürnberg, Germany, 90471
        • Recruiting
        • Klinikum Nürnberg - Klinikum Nürnberg Süd
  • Greece
      • Athen, Greece
        • Active, not recruiting
        • Hellenic Airforce 251 General Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Active, not recruiting
        • Prince of Wales Hospital
      • Hong Kong, Hong Kong
        • Active, not recruiting
        • The University of Hong Kong
  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Országos Klinikai Idegtudományi Intézet
  • Israel
      • Jerusalem, Israel
        • Terminated
        • Hadassah Medical Organization
      • Ramat Gan, Israel
        • Active, not recruiting
        • Sheba Medical Center
  • Italy
      • Firenze, Italy
        • Active, not recruiting
        • Azienda Ospedaliero-Universitaria Careggi
      • Milan, Italy, 20133
        • Active, not recruiting
        • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
      • Milano, Italy
        • Recruiting
        • Azienda Ospedaliera Ospedale Niguarda CA Granda
  • Korea, Republic of
      • Daejeon, Korea, Republic of, 301-721
        • Recruiting
        • Chungnam National University Hospital
      • Gwangju, Korea, Republic of, 61453
        • Recruiting
        • Chosun university hospital
      • Gwangju, Korea, Republic of, 102-602
        • Recruiting
        • Chonnam National University Hospital
      • Jeonju, Korea, Republic of, 54907
        • Recruiting
        • Jeonbuk National University Hospital
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
      • Suwon, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Medical Center
      • Ulsan, Korea, Republic of, 44033
        • Recruiting
        • Ulsan University Hospital
  • Poland
      • Warszawa, Poland, 04-141
        • Active, not recruiting
        • Military Medical Institute-Wojskowy Instytut Medyczny
  • Portugal
      • Vila Nova de Gaia, Portugal, 4434-502
        • Active, not recruiting
        • Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
  • Russian Federation
      • Novosibirsk, Russian Federation
        • Active, not recruiting
        • Siberian Federal Biomedical Research Center
      • St. Petersburg, Russian Federation
        • Active, not recruiting
        • Almazov National Medical Research Centre
  • Slovakia
      • Bratislava, Slovakia
        • Active, not recruiting
        • CINRE s.r.o.
  • South Africa
      • Johannesburg, South Africa
        • Withdrawn
        • Chris Hani Baragwaneth Hospital
  • Spain
      • Barakaldo, Spain
        • Active, not recruiting
        • Hospital de Cruces
      • Barcelona, Spain
        • Recruiting
        • Hospital Vall d'Hebron
      • Madrid, Spain
        • Withdrawn
        • Hospital Fundación Jiménez Díaz
      • Madrid, Spain
        • Active, not recruiting
        • Hospital Universitario de La Paz
      • Oviedo, Spain
        • Active, not recruiting
        • Hospital Universitario Central de Asturias
      • San Sebastián, Spain
        • Recruiting
        • Hospital Universitario Donostia
      • Sevilla, Spain, 41013
        • Active, not recruiting
        • Hospital Universitario Virgen del Rocio
      • Valladolid, Spain
        • Active, not recruiting
        • Hospital Clínico Universitario de Valladolid
      • Vigo, Spain, 36312
        • Recruiting
        • Hospital Alvaro Cunqueiro
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Universitätsspital Basel
      • Bern, Switzerland
        • Active, not recruiting
        • Inselspital - Universitätsspital Bern
      • Geneve, Switzerland
        • Active, not recruiting
        • Hôpitaux universitaires de Genève
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Active, not recruiting
        • Cleveland Clinic - Abu Dhabi
  • United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
      • 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
        • Active, not 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 market approved Medtronic flow diverters, intrasaccular devices or vascular reconstruction devices are eligible for the registry.

Acute Ischemic Stroke: Patients requiring treatment for Acute Ischemic Stroke due to intracranial vessel occlusion with Medtronic market approved aspiration and/or revascularization devices are eligible for the study.

Description

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.

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

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.

Sponsor

Medtronic Neurovascular Clinical Affairs

Collaborators

Medtronic Bakken Research Center

Investigators

  • Study Chair: 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, 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

December 1, 2016

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

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)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDT16056/MDT17077

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only multi center data will be available

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.

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