Clinical trial NCT02988128: Neurovascular Product Surveillance Registry
Official title: NeuroVascular Product Surveillance Registry (PSR) Platform
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Aspiration Catheter
Revascularization Device
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
Collaborators: name: Medtronic Cardiac Rhythm and Heart Failure
First posted: 2016-12-09
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility criteria: For MDT16056 and MDT17077

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.

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.

Primary outcomes:
measure: The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (≤ 50%).
timeFrame: 1 year
measure: Functional Independence: mRS score ≤ 2
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: ENERI
city: Southport
country: Australia
facility: Gold Coast University Hospital
city: Salzburg
country: Austria
facility: Universitätsklinikum Christian Doppler Klinik Salzburg
city: Genk
country: Belgium
facility: Ziekenhuis Oost Limburg - Campus Sint-Jan
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital
city: Ji'an
country: China
facility: The Affiliated Hospital of Jinggangshan University
city: Jiamusi
country: China
facility: First Affiliated Hospital of Jiamusi University
city: Kaifeng
country: China
facility: Kaifeng Central Hospital
city: Liaocheng
country: China
facility: Liaocheng People's Hospital
city: Lishui
country: China
facility: Lishui Municipal Central Hospital
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
city: Nanning
country: China
facility: The Second Nanning Peoples Hospital
city: Panzhihua
country: China
facility: Panzhihua Central Hospital
city: Qujing
country: China
facility: Qujing First Peoples Hospital
city: Shanghai
country: China
facility: Yangpu District Central Hospital Shanghai Yangpu Hospital Tongji University
city: Taiyuan
country: China
facility: Shanxi Cardiovascular Hospital
city: Xi'an
country: China
facility: The First Affiliated Hospital Of Xi'an Jiaotong University
city: Xianyang
country: China
facility: The First Peoples Hospital of Xianyang
city: Zhangzhou
country: China
facility: Zhangzhou Municipal Hospital of Fujian Province
city: Zhuhai
country: China
facility: Zhuhai Peoples Hospital
city: Zhumadian
country: China
facility: Zhumadian Central Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Turku
country: Finland
facility: Turun Yliopistollinen keskussairaala
city: Besançon
country: France
facility: CHU Besancon - Hôpital Jean Minjoz
city: Bordeaux
country: France
facility: CHU de Bordeaux - Centre Universitaire Pellegrin
city: Brest
country: France
facility: CHU Brest, Hôpital de la Cavale Blanche
city: Bron
country: France
facility: Hôpital Pierre Wertheimer
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
city: Dijon
country: France
facility: CHU Dijon Bourgogne
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP Hôpital Bicêtre
city: Limoges
country: France
facility: CHU Limoges - Hôpital Dupuytren
city: Marseille
country: France
facility: Hôpital de la Timone-CHU de Marseille
city: Montpellier
country: France
facility: CHU de Montpellier - Hôpital Gui de Chauliac
city: Nancy
country: France
facility: CHU de Nancy - Hôpital Central
city: Nantes
country: France
facility: CHU de Nantes Hôpital Laennec
city: Paris
country: France
facility: GHU Paris Psychiatrie & Neurosciences
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
city: Paris
country: France
facility: Hôpital de la Pitié Salpétrière
city: Reims
country: France
facility: CHU Reims Hôpital Maison Blanche
city: Rouen
country: France
facility: CHU Hôpitaux de Rouen - Hôpital Charles Nicolle
city: Toulouse
country: France
facility: CHU Toulouse - Hôpital Pierre-Paul Riquet
city: Tours
country: France
facility: CHRU de Tours - Hôpital Brettoneau
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique Vannes - Auray
city: Augsburg
country: Germany
facility: Klinikum Augsburg
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin -Campus Charite
city: Bochum
country: Germany
facility: Knappschaftskrankenhaus Bochum-Langendreer - Universitätsklinik
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt
city: Erlangen
country: Germany
facility: Universitätsklinikum Erlangen
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Munich
country: Germany
facility: LMU Klinikum der Universität München
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg - Klinikum Nürnberg Süd
city: Athen
country: Greece
facility: Hellenic Airforce 251 General Hospital
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
city: Budapest
country: Hungary
facility: Országos Klinikai Idegtudományi Intézet
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Firenze
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Milano
country: Italy
facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda
city: Milan
country: Italy
facility: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Jeonju
country: Korea, Republic of
facility: Jeonbuk National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Warszawa
country: Poland
facility: Military Medical Institute-Wojskowy Instytut Medyczny
city: Vila Nova de Gaia
country: Portugal
facility: Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I
city: Novosibirsk
country: Russian Federation
facility: Siberian Federal Biomedical Research Center
city: St. Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
city: Bratislava
country: Slovakia
facility: CINRE s.r.o.
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwaneth Hospital
city: Barakaldo
country: Spain
facility: Hospital De Cruces
city: Barcelona
country: Spain
facility: Hospital Vall D'Hebron
city: Madrid
country: Spain
facility: Hospital Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital Universitario de La Paz
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: San Sebastián
country: Spain
facility: Hospital Universitario Donostia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
city: Vigo
country: Spain
facility: Hospital Álvaro Cunqueiro
city: Basel
country: Switzerland
facility: Universitätsspital Basel
city: Bern
country: Switzerland
facility: Inselspital - Universitätsspital Bern
city: Geneve
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Abu Dhabi
country: United Arab Emirates
facility: Cleveland Clinic - Abu Dhabi
city: Birmingham
country: United Kingdom
facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital
city: Romford
country: United Kingdom
facility: Barking, Havering and Redbridge University Hospitals - Queen's Hospital
city: Stoke on Trent
country: United Kingdom
facility: University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
Study officials:
affiliation: Klinikum Nürnberg Süd
name: Markus Holtmannspotter, MD
role: STUDY_CHAIR
affiliation: Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et Pédiatrique
name: Laurent Spelle, MD
role: STUDY_CHAIR
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Jens Fiehler, MD
role: STUDY_CHAIR
affiliation: National Institute of Clinical Neurosciences
name: István Szikora, MD
role: STUDY_CHAIR
affiliation: Hospital Clínico Universitario de Valladolid
name: Mario Galdamez, MD
role: STUDY_CHAIR
affiliation: Queen Elisabeth Hospital, Neuroradiology
name: Saleh Lamin, MD
role: STUDY_CHAIR
affiliation: Hôpital Pierre Wertheimer
name: Francis Turjman, MD
role: STUDY_CHAIR
affiliation: CHU Toulouse - Hôpital Purpan
name: Christophe Cognard, MD
role: STUDY_CHAIR
affiliation: University Hospital Heidelberg
name: Markus Möhlenbruch, MD
role: STUDY_CHAIR
affiliation: Hospital Vall d'Hebron
name: Marc Ribó, MD
role: STUDY_CHAIR
affiliation: Inselspital - Universitätsspital Bern
name: Pasquale Mordasini, MD
role: STUDY_CHAIR
affiliation: University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital
name: Sanjeev Nayak, MD
role: STUDY_CHAIR
affiliation: Turun Yliopistollinen keskussairaala
name: Riitta Rautio, MD
role: STUDY_CHAIR
affiliation: Universitätsklinikum Christian Doppler Klinik Salzburg
name: Monika Killer-Oberpfalzer, MD
role: STUDY_CHAIR
References: