Stroke, Ischemic Clinical Trial
— INSPIREOfficial title:
NeuroVascular Product Surveillance Registry (PSR) Platform
Post market surveillance registry
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Medtronic Neurovascular Clinical Affairs | Medtronic Bakken Research Center |
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,
| 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 |
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