INSPIRE: Neurovascular Product Surveillance Registry

Sponsor

Medtronic Neurovascular Clinical Affairs (Industry)

Overall Status

Recruiting

CT.gov ID

NCT02988128

Collaborator

Medtronic Bakken Research Center (Industry)

3,000

Enrollment

Locations

119

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Post market surveillance registry

Condition or Disease	Intervention/Treatment	Phase
Intracranial Aneurysm Stroke, Ischemic	Device: Treatment for intracranial aneurysms Device: Treatment for Acute Ischemic Stroke

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.

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

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

3000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

NeuroVascular Product Surveillance Registry (PSR) Platform

Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2026

Anticipated Study Completion Date :

Nov 1, 2026

Outcome Measures

Primary Outcome Measures

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%).
Functional Independence: mRS score ≤ 2 [90 days]
For Acute ischemic stroke the primary outcome is functional Independence: modified Rankin Scale (mRS) score ≤ 2

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	ENERI	Buenos Aires	Argentina
2	Gold Coast University Hospital	Southport	Australia
3	Ziekenhuis Oost Limburg - Campus Sint-Jan	Genk	Belgium
4	Universitair Ziekenhuis Gent	Gent	Belgium
5	Rigshospitalet	Copenhagen	Denmark
6	Turun Yliopistollinen keskussairaala	Turku	Finland
7	CHU Besancon - Hôpital Jean Minjoz	Besançon	France
8	CHU Brest, Hôpital de la Cavale Blanche	Brest	France
9	Hôpital Pierre Wertheimer	Bron	France
10	CHU de Caen	Caen	France
11	AP-HP Hôpital Bicêtre	Le Kremlin-Bicêtre	France
12	CHU Limoges - Hôpital Dupuytren	Limoges	France
13	Hôpital de la Timone-CHU de Marseille	Marseille	France
14	CHU de Montpellier - Hôpital Gui de Chauliac	Montpellier	France
15	CHU de Nancy - Hôpital Central	Nancy	France	54035
16	CHU de Nantes Hôpital Laennec	Nantes	France
17	GHU Paris Psychiatrie & Neurosciences	Paris	France	75014
18	Fondation Ophtalmologique Adolphe de Rothschild	Paris	France
19	Hôpital de la Pitié Salpétrière	Paris	France
20	CHU Reims Hôpital Maison Blanche	Reims	France
21	CHU Hôpitaux de Rouen - Hôpital Charles Nicolle	Rouen	France
22	CHU Toulouse - Hôpital Pierre-Paul Riquet	Toulouse	France
23	Klinikum Augsburg	Augsburg	Germany
24	Charité Universitätsmedizin Berlin -Campus Charite	Berlin	Germany
25	HELIOS Klinikum Erfurt	Erfurt	Germany
26	Universitätsklinikum Erlangen	Erlangen	Germany
27	Alfried Krupp Krankenhaus	Essen	Germany
28	Universitätsklinikum Freiburg	Freiburg	Germany	79065
29	Universitätsklinikum Hamburg-Eppendorf	Hamburg	Germany
30	Universitätsklinikum Heidelberg	Heidelberg	Germany
31	Hellenic Airforce 251 General Hospital	Athen	Greece
32	Prince of Wales Hospital	Hong Kong	Hong Kong
33	The University of Hong Kong	Hong Kong	Hong Kong
34	Országos Klinikai Idegtudományi Intézet	Budapest	Hungary
35	Hadassah Medical Organization	Jerusalem	Israel
36	Sheba Medical Center	Ramat Gan	Israel
37	Azienda Ospedaliero-Universitaria Careggi	Firenze	Italy
38	Azienda Ospedaliera Ospedale Niguarda Cà Granda	Milano	Italy
39	Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta	Milan	Italy	20133
40	Military Medical Institute-Wojskowy Instytut Medyczny	Warszawa	Poland	04-141
41	Centro Hospitalar de Vila Nova de Gaia/Espinho - Unidade I	Vila Nova de Gaia	Portugal	4434-502
42	Siberian Federal Biomedical Research Center	Novosibirsk	Russian Federation
43	Almazov National Medical Research Centre	St. Petersburg	Russian Federation
44	CINRE s.r.o.	Bratislava	Slovakia
45	Chris Hani Baragwaneth Hospital	Johannesburg	South Africa
46	Hospital De Cruces	Barakaldo	Spain
47	Hospital Vall D'Hebron	Barcelona	Spain
48	Hospital Fundación Jiménez Díaz	Madrid	Spain
49	Hospital Universitario de La Paz	Madrid	Spain
50	Hospital Universitario Central de Asturias	Oviedo	Spain
51	Hospital Universitario Donostia	San Sebastián	Spain
52	Hospital Universitario Virgen del Rocío	Sevilla	Spain	41013
53	Hospital Clínico Universitario de Valladolid	Valladolid	Spain
54	Hospital Álvaro Cunqueiro	Vigo	Spain	36312
55	Inselspital - Universitätsspital Bern	Bern	Switzerland
56	Hôpitaux Universitaires de Genève	Geneve	Switzerland
57	Cleveland Clinic - Abu Dhabi	Abu Dhabi	United Arab Emirates
58	University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital	Birmingham	United Kingdom
59	Barking, Havering and Redbridge University Hospitals - Queen's Hospital	Romford	United Kingdom
60	University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital	Stoke on Trent	United Kingdom	ST4 6QG

Sponsors and Collaborators

Medtronic Neurovascular Clinical Affairs
Medtronic Bakken Research Center

Investigators

Study Chair: Markus Holtmannspotter, MD, Klinikum Nürnberg Süd
Study Chair: Laurent Spelle, MD, Hôpital Bicêtre, Service de Neuroradiologie Interventionnelle Adulte et Pédiatrique
Study Chair: Jens Fiehler, MD, Universitätsklinikum Hamburg-Eppendorf
Study Chair: István Szikora, MD, National Institute of Clinical Neurosciences
Study Chair: Mario Galdamez, MD, Hospital Clínico Universitario de Valladolid
Study Chair: Saleh Lamin, MD, Queen Elisabeth Hospital, Neuroradiology
Study Chair: Francis Turjman, MD, Hôpital Pierre Wertheimer
Study Chair: Christophe Cognard, MD, CHU Toulouse - Hôpital Purpan
Study Chair: Markus Möhlenbruch, MD, University Hospital Heidelberg
Study Chair: Marc Ribó, MD, Hospital Vall d'Hebron
Study Chair: Pasquale Mordasini, MD, Inselspital - Universitätsspital Bern
Study Chair: Sanjeev Nayak, MD, University Hospitals of North Midlands NHS Trust - Royal Stoke University Hospital