Neurovascular Product Surveillance Registry

Stroke, Ischemic Clinical Trial

— INSPIRE  

Official title:

NeuroVascular Product Surveillance Registry (PSR) Platform

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02988128
• Other study ID #: MDT16056/MDT17077
• Status: Recruiting
• Start date: December 2016
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: Medtronic Neurovascular Clinical Affairs
• Contact: Wouter Fabry
• Phone: +32496165078
• Email: wouter.fabry[@]medtronic.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Post market surveillance registry

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.

This study is conducted under the Product Surveillance Registry (NCT01524276).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Intracranial Aneurysm
• Ischemic Stroke
• Stroke, Ischemic

Intervention

Device:
• Treatment for intracranial aneurysms
Embolization of aneurysms
• Treatment for Acute Ischemic Stroke
Revascularization of an intracranial blood vessel

Locations

Country	Name	City	State
Argentina	ENERI	Buenos Aires
Australia	Gold Coast University Hospital	Southport
Austria	Universitätsklinikum Christian Doppler Klinik Salzburg	Salzburg
Belgium	Ziekenhuis Oost Limburg - Campus Sint-Jan	Genk
Belgium	Universitair Ziekenhuis Gent	Gent
China	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	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
Denmark	Rigshospitalet	Copenhagen
Finland	Turun Yliopistollinen keskussairaala	Turku
France	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	Fondation Ophtalmologique Adolphe de Rothschild	Paris
France	GHU Paris Psychiatrie & Neurosciences	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
Germany	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
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Heidelberg	Heidelberg
Germany	LMU Klinikum der Universität München	Munich
Germany	Klinikum Nürnberg - Klinikum Nürnberg Süd	Nürnberg
Greece	Hellenic Airforce 251 General Hospital	Athen
Hong Kong	Prince of Wales Hospital	Hong Kong
Hong Kong	The University of Hong Kong	Hong Kong
Hungary	Országos Klinikai Idegtudományi Intézet	Budapest
Israel	Hadassah Medical Organization	Jerusalem
Israel	Sheba Medical Center	Ramat Gan
Italy	Azienda Ospedaliero-Universitaria Careggi	Firenze
Italy	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	Milan
Italy	Azienda Ospedaliera Ospedale Niguarda Cà Granda	Milano
Korea, Republic of	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	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Severance Hospital	Seoul
Korea, Republic of	Ajou University Medical Center	Suwon
Korea, Republic of	Ulsan University Hospital	Ulsan
Poland	Military Medical Institute-Wojskowy Instytut Medyczny	Warszawa
Portugal	Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I	Vila Nova de Gaia
Russian Federation	Siberian Federal Biomedical Research Center	Novosibirsk
Russian Federation	Almazov National Medical Research Centre	St. Petersburg
Slovakia	CINRE s.r.o.	Bratislava
South Africa	Chris Hani Baragwaneth Hospital	Johannesburg
Spain	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	Sevilla
Spain	Hospital Clínico Universitario de Valladolid	Valladolid
Spain	Hospital Álvaro Cunqueiro	Vigo
Switzerland	Universitätsspital Basel	Basel
Switzerland	Inselspital - Universitätsspital Bern	Bern
Switzerland	Hôpitaux Universitaires de Genève	Geneve
United Arab Emirates	Cleveland Clinic - Abu Dhabi	Abu Dhabi
United Kingdom	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

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Neurovascular Clinical Affairs	Medtronic Bakken Research Center

Countries where clinical trial is conducted

Argentina,  Australia,  Austria,  Belgium,  China,  Denmark,  Finland,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Israel,  Italy,  Korea, Republic of,  Poland,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  Switzerland,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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%).	1 year
Primary	Functional Independence: mRS score = 2	For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score = 2	90 days