Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4000 participants
OBSERVATIONAL
2016-12-31
2032-08-31
Brief Summary
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Detailed Description
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MDT16056 and MDT17077 are conducted under the Product Surveillance Registry (NCT01524276).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
Interventions
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Treatment for intracranial aneurysms
Embolization of aneurysms
Treatment for Acute Ischemic Stroke
Revascularization of an intracranial blood vessel
Eligibility Criteria
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Inclusion Criteria
* 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 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
Exclusion Criteria
* 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:
* 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.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Medtronic Neurovascular Clinical Affairs
INDUSTRY
Responsible Party
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Principal Investigators
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Markus Holtmannspotter, MD
Role: STUDY_CHAIR
Klinikum Nürnberg Süd
Laurent Spelle, MD
Role: STUDY_CHAIR
Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et Pédiatrique
Jens Fiehler, MD
Role: STUDY_CHAIR
Universitätsklinikum Hamburg-Eppendorf
István Szikora, MD
Role: STUDY_CHAIR
National Institute of Clinical Neurosciences
Mario Galdamez, MD
Role: STUDY_CHAIR
Hospital Clínico Universitario de Valladolid
Saleh Lamin, MD
Role: STUDY_CHAIR
Queen Elisabeth Hospital, Neuroradiology
Francis Turjman, MD
Role: STUDY_CHAIR
Hôpital Pierre Wertheimer
Christophe Cognard, MD
Role: STUDY_CHAIR
CHU Toulouse - Hôpital Purpan
Markus Möhlenbruch, MD
Role: STUDY_CHAIR
University Hospital Heidelberg
Marc Ribó, MD
Role: STUDY_CHAIR
Hospital Vall d'Hebron
Pasquale Mordasini, MD
Role: STUDY_CHAIR
Inselspital - Universitätsspital Bern
Sanjeev Nayak, MD
Role: STUDY_CHAIR
University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
Riitta Rautio, MD
Role: STUDY_CHAIR
Turun Yliopistollinen keskussairaala
Monika Killer-Oberpfalzer, MD
Role: STUDY_CHAIR
Universitätsklinikum Christian Doppler Klinik Salzburg
Locations
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ENERI
Buenos Aires, , Argentina
Gold Coast University Hospital
Southport, , Australia
Universitätsklinikum Christian Doppler Klinik Salzburg
Salzburg, , Austria
Ziekenhuis Oost Limburg - Campus Sint-Jan
Genk, , Belgium
Universitair Ziekenhuis Gent
Ghent, , Belgium
Xuanwu Hospital Capital Medical University
Beijing, , China
Chongqing University Three Gorges Hospital
Chongqing, , China
First Affiliated Hospital of Jiamusi University
Jiamusi, , China
The Affiliated Hospital of Jinggangshan University
Ji’an, , China
Kaifeng Central Hospital
Kaifeng, , China
Liaocheng People's Hospital
Liaocheng, , China
Lishui Municipal Central Hospital
Lishui, , China
The Second Affiliated Hospital of Nanchang University
Nanchang, , China
The Second Nanning Peoples Hospital
Nanning, , China
Panzhihua Central Hospital
Panzhihua, , China
Qujing First Peoples Hospital
Qujing, , China
Yangpu District Central Hospital Shanghai Yangpu Hospital Tongji University
Shanghai, , China
Shanxi Cardiovascular Hospital
Taiyuan, , China
The First Affiliated Hospital Of Xi'an Jiaotong University
Xi'an, , China
The First Peoples Hospital of Xianyang
Xianyang, , China
Zhangzhou Municipal Hospital of Fujian Province
Zhangzhou, , China
Zhuhai Peoples Hospital
Zhuhai, , China
Zhumadian Central Hospital
Zhumadian, , China
Rigshospitalet
Copenhagen, , Denmark
Turun Yliopistollinen keskussairaala
Turku, , Finland
CHU Besancon - Hôpital Jean Minjoz
Besançon, , France
CHU de Bordeaux - Centre Universitaire Pellegrin
Bordeaux, , France
CHU Brest, Hôpital de la Cavale Blanche
Brest, , France
Hôpital Pierre Wertheimer
Bron, , France
CHU de Caen
Caen, , France
Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
Clermont-Ferrand, , France
CHU Dijon Bourgogne
Dijon, , France
AP-HP Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
CHU Limoges - Hôpital Dupuytren
Limoges, , France
Hôpital de la Timone-CHU de Marseille
Marseille, , France
CHU de Montpellier - Hôpital Gui de Chauliac
Montpellier, , France
CHU de Nancy - Hôpital Central
Nancy, , France
CHU de Nantes Hôpital Laennec
Nantes, , France
GHU Paris Psychiatrie & Neurosciences
Paris, , France
Fondation Ophtalmologique Adolphe de Rothschild
Paris, , France
Hôpital de la Pitié Salpétrière
Paris, , France
CHU Reims Hôpital Maison Blanche
Reims, , France
CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
Rouen, , France
CHU Toulouse - Hôpital Pierre-Paul Riquet
Toulouse, , France
CHRU de Tours - Hôpital Brettoneau
Tours, , France
Centre Hospitalier Bretagne Atlantique Vannes - Auray
Vannes, , France
Klinikum Augsburg
Augsburg, , Germany
Charité Universitätsmedizin Berlin -Campus Charite
Berlin, , Germany
Knappschaftskrankenhaus Bochum-Langendreer - Universitätsklinik
Bochum, , Germany
HELIOS Klinikum Erfurt
Erfurt, , Germany
Universitätsklinikum Erlangen
Erlangen, , Germany
Alfried Krupp Krankenhaus
Essen, , Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
LMU Klinikum der Universität München
Munich, , Germany
Klinikum Nürnberg - Klinikum Nürnberg Süd
Nuremberg, , Germany
Hellenic Airforce 251 General Hospital
Athens, , Greece
Prince of Wales Hospital
Hong Kong, , Hong Kong
The University of Hong Kong
Hong Kong, , Hong Kong
Országos Klinikai Idegtudományi Intézet
Budapest, , Hungary
Hadassah Medical Organization
Jerusalem, , Israel
Sheba Medical Center
Ramat Gan, , Israel
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Milan, , Italy
Azienda Ospedaliera Ospedale Niguarda Cà Granda
Milan, , Italy
Military Medical Institute-Wojskowy Instytut Medyczny
Warsaw, , Poland
Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
Vila Nova de Gaia, , Portugal
Siberian Federal Biomedical Research Center
Novosibirsk, , Russia
Almazov National Medical Research Centre
Saint Petersburg, , Russia
CINRE s.r.o.
Bratislava, , Slovakia
Chris Hani Baragwaneth Hospital
Johannesburg, , South Africa
Chungnam National University Hospital
Daejeon, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Chosun University Hospital
Gwangju, , South Korea
Jeonbuk National University Hospital
Jeonju, , South Korea
Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Ajou University Medical Center
Suwon, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Hospital De Cruces
Barakaldo, , Spain
Hospital Vall D'Hebron
Barcelona, , Spain
Hospital Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario de La Paz
Madrid, , Spain
Hospital Universitario Central de Asturias
Oviedo, , Spain
Hospital Universitario Donostia
San Sebastián, , Spain
Hospital Universitario Virgen del Rocío
Seville, , Spain
Hospital Clínico Universitario de Valladolid
Valladolid, , Spain
Hospital Álvaro Cunqueiro
Vigo, , Spain
Universitätsspital Basel
Basel, , Switzerland
Inselspital - Universitätsspital Bern
Bern, , Switzerland
Hôpitaux Universitaires de Genève
Geneva, , Switzerland
Cleveland Clinic - Abu Dhabi
Abu Dhabi, , United Arab Emirates
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
Birmingham, , United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, , United Kingdom
Imperial College Healthcare NHS Trust - Charing Cross Hospital
London, , United Kingdom
Barking, Havering and Redbridge University Hospitals - Queen's Hospital
Romford, , United Kingdom
University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
Stoke-on-Trent, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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MDT16056/17077/24028/22032
Identifier Type: -
Identifier Source: org_study_id