Intracranial AneurysmINSPIRENCT02988128
Neurovascular Product Surveillance Registry
An observational study of Intracranial Aneurysm and Stroke, Ischemic, run by Medtronic Neurovascular Clinical Affairs at 99 sites in 24 countries.
Trial summary
Post market surveillance registry Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm, Stroke, Ischemic
- What is being tested?
- Treatment for intracranial aneurysms and Treatment for Acute Ischemic Stroke
- Type of treatment
- Medical device
- How many people
- 4,000 participants
- Where
- 99 sitesin 24 countries
- Study dates
- Dec 2016to Aug 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 15Show fewer
- 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.
Trial locations and contacts
99 sites in 24 countries. Contact the study team or a site near you to ask about taking part.
99 sites in 24 countries
France21 sites, 12 recruiting
- Recruiting
CHU Besancon - Hôpital Jean Minjoz
Besançon
- Completed
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux, 33000
- Recruiting
CHU Brest, Hôpital de la Cavale Blanche
Brest
- Recruiting
Hôpital Pierre Wertheimer
Bron
- Completed
CHU de Caen
Caen
- Completed
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand, 63003
- Completed
CHU Dijon Bourgogne
Dijon, 21079
- Recruiting
AP-HP Hôpital Bicêtre
Le Kremlin-Bicêtre
- Recruiting
CHU Limoges - Hôpital Dupuytren
Limoges
- Recruiting
Hôpital de la Timone-CHU de Marseille
Marseille
- Recruiting
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier
- Terminated
CHU de Nancy - Hôpital Central
Nancy, 54035
- Active, not recruiting
CHU de Nantes Hôpital Laennec
Nantes
- Completed
GHU Paris Psychiatrie & Neurosciences
Paris, 75014
- Recruiting
Fondation Ophtalmologique Adolphe de Rothschild
Paris
- Recruiting
Hôpital de la Pitié Salpétrière
Paris
- Withdrawn
CHU Reims Hôpital Maison Blanche
Reims
- Recruiting
CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
Rouen
- Recruiting
CHU Toulouse - Hôpital Pierre-Paul Riquet
Toulouse
- Recruiting
CHRU de Tours - Hôpital Brettoneau
Tours, 37000
- Completed
Centre Hospitalier Bretagne Atlantique Vannes - Auray
Vannes, 56000
China18 sites
- Completed
Xuanwu Hospital Capital Medical University
Beijing, 100053
- Completed
Chongqing University Three Gorges Hospital
Chongqing, 404000
- Completed
The Affiliated Hospital of Jinggangshan University
Ji’an, 343600
- Terminated
First Affiliated Hospital of Jiamusi University
Jiamusi, 154000
- Terminated
Kaifeng Central Hospital
Kaifeng, 475000
- Terminated
Liaocheng People's Hospital
Liaocheng, 252001
- Terminated
Lishui Municipal Central Hospital
Lishui, 323020
- Terminated
The Second Affiliated Hospital of Nanchang University
Nanchang, 330006
- Completed
The Second Nanning Peoples Hospital
Nanning, 530031
- Terminated
Panzhihua Central Hospital
Panzhihua, 617067
- Terminated
Qujing First Peoples Hospital
Qujing, 655000
- Completed
Yangpu District Central Hospital Shanghai Yangpu Hospital Tongji University
Shanghai, 200082
- Completed
Shanxi Cardiovascular Hospital
Taiyuan, 30024
- Completed
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, 710061
- Completed
The First Peoples Hospital of Xianyang
Xianyang, 712000
- Completed
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, 363000
- Terminated
Zhuhai Peoples Hospital
Zhuhai, 519070
- Completed
Zhumadian Central Hospital
Zhumadian, 463000
Germany11 sites, 4 recruiting
- Withdrawn
Klinikum Augsburg
Augsburg
- Completed
Charité Universitätsmedizin Berlin -Campus Charite
Berlin
- Suspended
Knappschaftskrankenhaus Bochum-Langendreer - Universitätsklinik
Bochum, 44892
- Withdrawn
HELIOS Klinikum Erfurt
Erfurt
- Suspended
Universitätsklinikum Erlangen
Erlangen
- Completed
Alfried Krupp Krankenhaus
Essen
- Recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79065
- Withdrawn
Universitätsklinikum Hamburg-Eppendorf
Hamburg
- Recruiting
Universitätsklinikum Heidelberg
Heidelberg
- Recruiting
LMU Klinikum der Universität München
Munich, 80336
- Recruiting
Klinikum Nürnberg - Klinikum Nürnberg Süd
Nuremberg, 90471
South Korea9 sites
- Completed
Chungnam National University Hospital
Daejeon, 301-721
- Completed
Chonnam National University Hospital
Gwangju, 102-602
- Completed
Chosun University Hospital
Gwangju, 61453
- Completed
Jeonbuk National University Hospital
Jeonju, 54907
- Withdrawn
Severance Hospital
Seoul, 03722
- Completed
Samsung Medical Center
Seoul, 06351
- Completed
Asan Medical Center
Seoul, 138-736
- Completed
Ajou University Medical Center
Suwon, 16499
- Completed
Ulsan University Hospital
Ulsan, 44033
Spain9 sites, 5 recruiting
- Completed
Hospital De Cruces
Barakaldo
- Recruiting
Hospital Vall D'Hebron
Barcelona
- Withdrawn
Hospital Fundación Jiménez Díaz
Madrid
- Completed
Hospital Universitario de La Paz
Madrid
- Recruiting
Hospital Universitario Central de Asturias
Oviedo
- Recruiting
Hospital Universitario Donostia
San Sebastián
- Completed
Hospital Universitario Virgen del Rocío
Seville, 41013
- Recruiting
Hospital Clínico Universitario de Valladolid
Valladolid
- Recruiting
Hospital Álvaro Cunqueiro
Vigo, 36312
United Kingdom5 sites, 5 recruiting
- Recruiting
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA
- Recruiting
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, W6 8RF
- Recruiting
Barking, Havering and Redbridge University Hospitals - Queen's Hospital
Romford
- Recruiting
University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
Italy3 sites, 1 recruiting
- Completed
Azienda Ospedaliero-Universitaria Careggi
Florence
- Active, not recruiting
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, 20133
- Recruiting
Azienda Ospedaliera Ospedale Niguarda Cà Granda
Milan
Switzerland3 sites, 1 recruiting
- Recruiting
Universitätsspital Basel
Basel, 4031
- Completed
Inselspital - Universitätsspital Bern
Bern
- Completed
Hôpitaux Universitaires de Genève
Geneva
Belgium2 sites
- Completed
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk
- Completed
Universitair Ziekenhuis Gent
Ghent
Hong Kong2 sites
- Active, not recruiting
Prince of Wales Hospital
Hong Kong
- Completed
The University of Hong Kong
Hong Kong
Israel2 sites, 1 recruiting
- Terminated
Hadassah Medical Organization
Jerusalem
- Recruiting
Sheba Medical Center
Ramat Gan
Russia2 sites
- Completed
Siberian Federal Biomedical Research Center
Novosibirsk
- Completed
Almazov National Medical Research Centre
Saint Petersburg
Australia1 site
- Active, not recruiting
Gold Coast University Hospital
Southport
Austria1 site, 1 recruiting
- Recruiting
Universitätsklinikum Christian Doppler Klinik Salzburg
Salzburg, 5020
Finland1 site, 1 recruiting
- Recruiting
Turun Yliopistollinen keskussairaala
Turku
Greece1 site, 1 recruiting
- Recruiting
Hellenic Airforce 251 General Hospital
Athens
Hungary1 site, 1 recruiting
- Recruiting
Országos Klinikai Idegtudományi Intézet
Budapest
Poland1 site
- Completed
Military Medical Institute-Wojskowy Instytut Medyczny
Warsaw, 04-141
Portugal1 site
- Completed
Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
Vila Nova de Gaia, 4434-502
United Arab Emirates1 site, 1 recruiting
- Recruiting
Cleveland Clinic - Abu Dhabi
Abu Dhabi
About this study
Official title: NeuroVascular Product Surveillance Registry (PSR) Platform
Post market surveillance registry
Read the 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).
- Conditions
- Intracranial Aneurysm, Stroke, Ischemic
- Being tested
- Treatment for intracranial aneurysms, Treatment for Acute Ischemic Stroke
- 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
- Medical subject headings
- Intracranial Aneurysm, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment for intracranial aneurysmsDevice
Embolization of aneurysms
Treatment for Acute Ischemic StrokeDevice
Revascularization of an intracranial blood vessel
| Study group | Role | What they receive |
|---|---|---|
| Intracranial aneurysm | Patients undergoing treatment for intracranial aneurysms (IA) with Medtronic market approved device(s). Receives: Device: Treatment for intracranial aneurysms | |
| Acute Ischemic Stroke | Patients undergoing treatment for acute ischemic stroke (AIS) with Medtronic market approved device(s). Receives: Device: Treatment for Acute Ischemic Stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 1 year
Functional Independence: mRS score ≤ 2
For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2032 (estimated)
- Study completionAug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medtronic Neurovascular Clinical Affairs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Responsible party
- Sponsor
- Investigators
- Markus Holtmannspotter, MD, Study chair, Klinikum Nürnberg SüdLaurent Spelle, MD, Study chair, Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et PédiatriqueJens Fiehler, MD, Study chair, Universitätsklinikum Hamburg-EppendorfIstván Szikora, MD, Study chair, National Institute of Clinical NeurosciencesMario Galdamez, MD, Study chair, Hospital Clínico Universitario de ValladolidSaleh Lamin, MD, Study chair, Queen Elisabeth Hospital, NeuroradiologyFrancis Turjman, MD, Study chair, Hôpital Pierre WertheimerChristophe Cognard, MD, Study chair, CHU Toulouse - Hôpital Purpan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988128
- Sponsor's protocol ID
- MDT16056/17077/24028/22032
- Acronym
- INSPIRE
- Status last verified
- Sep 2026
- First submitted
- 7 Dec 2016
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Only multi center data will be available
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NeuroVascular Product Surveillance Registry (PSR) Platform
- ClinicalTrials.gov ID
- NCT02988128
- Acronym / sponsor ID
- INSPIRE / MDT16056/17077/24028/22032
- Conditions
- Intracranial Aneurysm, Stroke, Ischemic
- Keywords
- Embolization Device, Flow Diverter, Intrasaccular device, Vascular Reconstruction Device, Ruptured Intracranial Aneurysm, Unruptured Intracranial Aneurysm, Large Vessel Occlusion, Stent Retriever
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Medtronic Neurovascular Clinical AffairsIndustry (pharma, biotech, devices)
- Collaborators
- Medtronic Cardiac Rhythm and Heart Failure
- Study start
- Dec 2016 (actual)
- Primary completion
- Aug 2032 (estimated)
- Study completion
- Aug 2032 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracranial aneurysm | – | Device: Treatment for intracranial aneurysmsPatients undergoing treatment for intracranial aneurysms (IA) with Medtronic market approved device(s). |
| Acute Ischemic Stroke | – | Device: Treatment for Acute Ischemic StrokePatients undergoing treatment for acute ischemic stroke (AIS) with Medtronic market approved device(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
- Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treatment for intracranial aneurysmsEmbolization of aneurysms | Device | Intracranial aneurysm |
| Treatment for Acute Ischemic StrokeRevascularization of an intracranial blood vessel | Device | Acute Ischemic Stroke |
Primary outcome
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%).
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. Only multi center data will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Markus Holtmannspotter, MD study chair
Klinikum Nürnberg Süd
Laurent Spelle, MD study chair
Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et Pédiatrique
Jens Fiehler, MD study chair
Universitätsklinikum Hamburg-Eppendorf
99 sites in 24 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Aneurysm and Stroke, Ischemic, run by Medtronic Neurovascular Clinical Affairs at 99 sites in 24 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 99 sites in France, China, Germany, South Korea, Spain and 19 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wouter Fabry (+32496165078, wouter.fabry@medtronic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%). (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.