Neurovascular Product Surveillance Registry
- Conditions
- Intracranial AneurysmStroke, Ischemic
- Interventions
- Device: Treatment for intracranial aneurysmsDevice: Treatment for Acute Ischemic Stroke
- Registration Number
- NCT02988128
- Lead Sponsor
- Medtronic Neurovascular Clinical Affairs
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 4000
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intracranial aneurysm Treatment for intracranial aneurysms Patients undergoing treatment for intracranial aneurysms (IA) with Medtronic market approved device(s). Acute Ischemic Stroke Treatment for Acute Ischemic Stroke Patients undergoing treatment for acute ischemic stroke (AIS) with Medtronic market approved device(s).
- Primary Outcome Measures
Name Time Method Functional Independence: mRS score ≤ 2 90 days For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2
The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%). 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%).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (98)
ENERI
🇦🇷Buenos Aires, Argentina
Klinikum Augsburg
🇩🇪Augsburg, Germany
Qujing First Peoples Hospital
🇨🇳Qujing, China
Centre Hospitalier Bretagne Atlantique Vannes - Auray
🇫🇷Vannes, France
Hospital Universitario de La Paz
🇪🇸Madrid, Spain
Gold Coast University Hospital
🇦🇺Southport, Australia
Universitätsklinikum Christian Doppler Klinik Salzburg
🇦🇹Salzburg, Austria
Ziekenhuis Oost Limburg - Campus Sint-Jan
🇧🇪Genk, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Xuanwu Hospital Capital Medical University
🇨🇳Beijing, China
Chongqing University Three Gorges Hospital
🇨🇳Chongqing, China
The Affiliated Hospital of Jinggangshan University
🇨🇳Ji'an, China
First Affiliated Hospital of Jiamusi University
🇨🇳Jiamusi, 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
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
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, Germany
Universitätsklinikum Hamburg-Eppendorf
🇩🇪Hamburg, Germany
Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
LMU Klinikum der Universität München
🇩🇪Munich, Germany
Klinikum Nürnberg - Klinikum Nürnberg Süd
🇩🇪Nürnberg, Germany
Hellenic Airforce 251 General Hospital
🇬🇷Athen, 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
🇮🇹Firenze, Italy
Azienda Ospedaliera Ospedale Niguarda Cà Granda
🇮🇹Milano, Italy
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
🇮🇹Milan, Italy
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Jeonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Medical Center
🇰🇷Suwon, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Military Medical Institute-Wojskowy Instytut Medyczny
🇵🇱Warszawa, Poland
Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
🇵🇹Vila Nova de Gaia, Portugal
Siberian Federal Biomedical Research Center
🇷🇺Novosibirsk, Russian Federation
Almazov National Medical Research Centre
🇷🇺St. Petersburg, Russian Federation
CINRE s.r.o.
🇸🇰Bratislava, Slovakia
Chris Hani Baragwaneth Hospital
🇿🇦Johannesburg, South Africa
Hospital De Cruces
🇪🇸Barakaldo, Spain
Hospital Vall D'Hebron
🇪🇸Barcelona, Spain
Hospital Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Spain
Hospital Universitario Donostia
🇪🇸San Sebastián, Spain
Hospital Universitario Virgen del Rocío
🇪🇸Sevilla, 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
🇨🇭Geneve, Switzerland
Cleveland Clinic - Abu Dhabi
🇦🇪Abu Dhabi, United Arab Emirates
University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
🇬🇧Birmingham, 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