ClinicalTrials.gg
RecruitingNCT02988128INSPIREUpdated Sep 15, 2026

Neurovascular Product Surveillance Registry

An observational study in Intracranial Aneurysm and Stroke, Ischemic, sponsored by Medtronic Neurovascular Clinical Affairs. Recruiting at 99 sites in 24 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Medtronic Neurovascular Clinical Affairs (part of Medtronic) · Observational

From the registry’s dates

  • Started Dec 2016; still recruiting 9 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,000
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • 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
  • Aspiration Catheter
  • Revascularization Device
03

In context

Intracranial Aneurysm

418 studies on the registry are indexed under Intracranial Aneurysm; 119 are open to participants now.

This study's planned enrollment of 4,000 is above the median of 200 across 191 observational studies indexed under Intracranial Aneurysm.

Browse Intracranial Aneurysm studies →

Lead sponsor

Medtronic Neurovascular Clinical Affairs is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

For MDT16056 and MDT17077

Inclusion criteria

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

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 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,000 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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

  • DeviceTreatment for intracranial aneurysms

    Embolization of aneurysms

  • DeviceTreatment for Acute Ischemic Stroke

    Revascularization of an intracranial blood vessel

06

What researchers measure

Primary outcomes

  1. 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%).

    Time frame: 1 year

  2. Functional Independence: mRS score ≤ 2

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

    Time frame: 90 days

07

Study locations

37 of 99 sites recruiting
  • ENERI
    Buenos Aires, Argentina
    Recruiting
  • Gold Coast University Hospital
    Southport, Australia
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Christian Doppler Klinik Salzburg
    Salzburg, 5020, Austria
    Recruiting
  • Ziekenhuis Oost Limburg - Campus Sint-Jan
    Genk, Belgium
    Completed

    Not enrolling at this site — choose another above.

  • Universitair Ziekenhuis Gent
    Ghent, Belgium
    Completed

    Not enrolling at this site — choose another above.

  • Xuanwu Hospital Capital Medical University
    Beijing, 100053, China
    Completed

    Not enrolling at this site — choose another above.

  • Chongqing University Three Gorges Hospital
    Chongqing, 404000, China
    Completed

    Not enrolling at this site — choose another above.

  • First Affiliated Hospital of Jiamusi University
    Jiamusi, 154000, China
    Terminated

    Not enrolling at this site — choose another above.

  • The Affiliated Hospital of Jinggangshan University
    Ji’an, 343600, China
    Completed

    Not enrolling at this site — choose another above.

  • Kaifeng Central Hospital
    Kaifeng, 475000, China
    Terminated

    Not enrolling at this site — choose another above.

  • Liaocheng People's Hospital
    Liaocheng, 252001, China
    Terminated

    Not enrolling at this site — choose another above.

  • Lishui Municipal Central Hospital
    Lishui, 323020, China
    Terminated

    Not enrolling at this site — choose another above.

  • The Second Affiliated Hospital of Nanchang University
    Nanchang, 330006, China
    Terminated

    Not enrolling at this site — choose another above.

  • The Second Nanning Peoples Hospital
    Nanning, 530031, China
    Completed

    Not enrolling at this site — choose another above.

  • Panzhihua Central Hospital
    Panzhihua, 617067, China
    Terminated

    Not enrolling at this site — choose another above.

  • Qujing First Peoples Hospital
    Qujing, 655000, China
    Terminated

    Not enrolling at this site — choose another above.

  • Yangpu District Central Hospital Shanghai Yangpu Hospital Tongji University
    Shanghai, 200082, China
    Completed

    Not enrolling at this site — choose another above.

  • Shanxi Cardiovascular Hospital
    Taiyuan, 30024, China
    Completed

    Not enrolling at this site — choose another above.

  • The First Affiliated Hospital Of Xi'an Jiaotong University
    Xi'an, 710061, China
    Completed

    Not enrolling at this site — choose another above.

  • The First Peoples Hospital of Xianyang
    Xianyang, 712000, China
    Completed

    Not enrolling at this site — choose another above.

  • Zhangzhou Municipal Hospital of Fujian Province
    Zhangzhou, 363000, China
    Completed

    Not enrolling at this site — choose another above.

  • Zhuhai Peoples Hospital
    Zhuhai, 519070, China
    Terminated

    Not enrolling at this site — choose another above.

  • Zhumadian Central Hospital
    Zhumadian, 463000, China
    Completed

    Not enrolling at this site — choose another above.

  • 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

    Not enrolling at this site — choose another above.

  • CHU Brest, Hôpital de la Cavale Blanche
    Brest, France
    Recruiting
  • Hôpital Pierre Wertheimer
    Bron, France
    Recruiting
  • CHU de Caen
    Caen, France
    Completed

    Not enrolling at this site — choose another above.

  • Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
    Clermont-Ferrand, 63003, France
    Completed

    Not enrolling at this site — choose another above.

  • CHU Dijon Bourgogne
    Dijon, 21079, France
    Completed

    Not enrolling at this site — choose another above.

  • 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

    Not enrolling at this site — choose another above.

  • CHU de Nantes Hôpital Laennec
    Nantes, France
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • GHU Paris Psychiatrie & Neurosciences
    Paris, 75014, France
    Completed

    Not enrolling at this site — choose another above.

  • Fondation Ophtalmologique Adolphe de Rothschild
    Paris, France
    Recruiting
  • Hôpital de la Pitié Salpétrière
    Paris, France
    Recruiting
  • CHU Reims Hôpital Maison Blanche
    Reims, France
    Withdrawn

    Not enrolling at this site — choose another above.

  • 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

    Not enrolling at this site — choose another above.

  • Klinikum Augsburg
    Augsburg, Germany
    Withdrawn

    Not enrolling at this site — choose another above.

  • Charité Universitätsmedizin Berlin -Campus Charite
    Berlin, Germany
    Completed

    Not enrolling at this site — choose another above.

  • Knappschaftskrankenhaus Bochum-Langendreer - Universitätsklinik
    Bochum, 44892, Germany
    Suspended

    Not enrolling at this site — choose another above.

  • HELIOS Klinikum Erfurt
    Erfurt, Germany
    Withdrawn

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Erlangen
    Erlangen, Germany
    Suspended

    Not enrolling at this site — choose another above.

  • Alfried Krupp Krankenhaus
    Essen, Germany
    Completed

    Not enrolling at this site — choose another above.

  • Universitätsklinikum Freiburg
    Freiburg im Breisgau, 79065, Germany
    Recruiting
  • Universitätsklinikum Hamburg-Eppendorf
    Hamburg, Germany
    Withdrawn

    Not enrolling at this site — choose another above.

  • 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

    Not enrolling at this site — choose another above.

  • The University of Hong Kong
    Hong Kong, Hong Kong
    Completed

    Not enrolling at this site — choose another above.

  • Országos Klinikai Idegtudományi Intézet
    Budapest, Hungary
    Recruiting
  • Hadassah Medical Organization
    Jerusalem, Israel
    Terminated

    Not enrolling at this site — choose another above.

  • Sheba Medical Center
    Ramat Gan, Israel
    Recruiting
  • Azienda Ospedaliero-Universitaria Careggi
    Florence, Italy
    Completed

    Not enrolling at this site — choose another above.

  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
    Milan, 20133, Italy
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Azienda Ospedaliera Ospedale Niguarda Cà Granda
    Milan, Italy
    Recruiting
  • Military Medical Institute-Wojskowy Instytut Medyczny
    Warsaw, 04-141, Poland
    Completed

    Not enrolling at this site — choose another above.

  • Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
    Vila Nova de Gaia, 4434-502, Portugal
    Completed

    Not enrolling at this site — choose another above.

  • Siberian Federal Biomedical Research Center
    Novosibirsk, Russia
    Completed

    Not enrolling at this site — choose another above.

  • Almazov National Medical Research Centre
    Saint Petersburg, Russia
    Completed

    Not enrolling at this site — choose another above.

  • CINRE s.r.o.
    Bratislava, Slovakia
    Recruiting
  • Chris Hani Baragwaneth Hospital
    Johannesburg, South Africa
    Withdrawn

    Not enrolling at this site — choose another above.

  • Chungnam National University Hospital
    Daejeon, 301-721, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Chonnam National University Hospital
    Gwangju, 102-602, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Chosun University Hospital
    Gwangju, 61453, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Jeonbuk National University Hospital
    Jeonju, 54907, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Severance Hospital
    Seoul, 03722, South Korea
    Withdrawn

    Not enrolling at this site — choose another above.

  • Samsung Medical Center
    Seoul, 06351, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Asan Medical Center
    Seoul, 138-736, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Ajou University Medical Center
    Suwon, 16499, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Ulsan University Hospital
    Ulsan, 44033, South Korea
    Completed

    Not enrolling at this site — choose another above.

  • Hospital De Cruces
    Barakaldo, Spain
    Completed

    Not enrolling at this site — choose another above.

  • Hospital Vall D'Hebron
    Barcelona, Spain
    Recruiting
  • Hospital Fundación Jiménez Díaz
    Madrid, Spain
    Withdrawn

    Not enrolling at this site — choose another above.

  • Hospital Universitario de La Paz
    Madrid, Spain
    Completed

    Not enrolling at this site — choose another above.

  • Hospital Universitario Central de Asturias
    Oviedo, Spain
    Recruiting
  • Hospital Universitario Donostia
    San Sebastián, Spain
    Recruiting
  • Hospital Universitario Virgen del Rocío
    Seville, 41013, Spain
    Completed

    Not enrolling at this site — choose another above.

  • 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

    Not enrolling at this site — choose another above.

  • Hôpitaux Universitaires de Genève
    Geneva, Switzerland
    Completed

    Not enrolling at this site — choose another above.

  • 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
08

References and documents

Individual participant data

Plan to share: No — Only multi center data will be available

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2016 (actual). Primary completion is estimated for Aug 2032, 188 months after the start.

Of 104 observational studies under Intracranial Aneurysm, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 145. This study's planned 188 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 7, 2016
First posted
Dec 9, 2016
StartActual
Dec 2016
Primary completionEst.
Aug 2032
CompletionEst.
Aug 2032
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02988128
Responsible party
Sponsor
First posted
Dec 9, 2016
Start date
Dec 2016
Primary completion
Aug 2032 (estimated)
Completion
Aug 2032 (estimated)
Last update
Sep 15, 2026

Study contacts

Wouter Fabry
Contact
wouter.fabry@medtronic.com
+32496165078
Beatrice Carlotta Sicurella
Contact
beatrice.carlotta.sicurella@medtronic.com
+390224137264
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
István Szikora, MD
study chair · National Institute of Clinical Neurosciences
Mario Galdamez, MD
study chair · Hospital Clínico Universitario de Valladolid
Saleh Lamin, MD
study chair · Queen Elisabeth Hospital, Neuroradiology
Francis Turjman, MD
study chair · Hôpital Pierre Wertheimer
Christophe Cognard, MD
study chair · CHU Toulouse - Hôpital Purpan
Markus Möhlenbruch, MD
study chair · University Hospital Heidelberg
Marc Ribó, MD
study chair · Hospital Vall d'Hebron
Pasquale Mordasini, MD
study chair · Inselspital - Universitätsspital Bern
Sanjeev Nayak, MD
study chair · University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
Riitta Rautio, MD
study chair · Turun Yliopistollinen keskussairaala
Monika Killer-Oberpfalzer, MD
study chair · Universitätsklinikum Christian Doppler Klinik Salzburg

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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