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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02988128




Registration number
NCT02988128
Ethics application status
Date submitted
7/12/2016
Date registered
9/12/2016

Titles & IDs
Public title
Neurovascular Product Surveillance Registry
Scientific title
NeuroVascular Product Surveillance Registry (PSR) Platform
Secondary ID [1] 0 0
MDT16056/17077/24028/22032
Universal Trial Number (UTN)
Trial acronym
INSPIRE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intracranial Aneurysm 0 0
Stroke, Ischemic 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Treatment for intracranial aneurysms
Treatment: Devices - Treatment for Acute Ischemic Stroke

Intracranial aneurysm - Patients undergoing treatment for intracranial aneurysms (IA) with Medtronic market approved device(s).

Acute Ischemic Stroke - Patients undergoing treatment for acute ischemic stroke (AIS) with Medtronic market approved device(s).


Treatment: Devices: Treatment for intracranial aneurysms
Embolization of aneurysms

Treatment: Devices: Treatment for Acute Ischemic Stroke
Revascularization of an intracranial blood vessel
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The clinical success rate defined as complete occlusion of target aneurysm without retreatment or significant artery stenosis (= 50%).
Timepoint [1] 0 0
1 year
Primary outcome [2] 0 0
Functional Independence: mRS score = 2
Timepoint [2] 0 0
90 days

Eligibility
Key inclusion criteria
For MDT16056 and MDT17077



* 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

* 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2032
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 0 0
- Southport
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Salzburg
Country [3] 0 0
Belgium
State/province [3] 0 0
Genk
Country [4] 0 0
Belgium
State/province [4] 0 0
Gent
Country [5] 0 0
China
State/province [5] 0 0
Beijing
Country [6] 0 0
China
State/province [6] 0 0
Chongqing
Country [7] 0 0
China
State/province [7] 0 0
Ji'an
Country [8] 0 0
China
State/province [8] 0 0
Jiamusi
Country [9] 0 0
China
State/province [9] 0 0
Kaifeng
Country [10] 0 0
China
State/province [10] 0 0
Liaocheng
Country [11] 0 0
China
State/province [11] 0 0
Lishui
Country [12] 0 0
China
State/province [12] 0 0
Nanchang
Country [13] 0 0
China
State/province [13] 0 0
Nanning
Country [14] 0 0
China
State/province [14] 0 0
Panzhihua
Country [15] 0 0
China
State/province [15] 0 0
Qujing
Country [16] 0 0
China
State/province [16] 0 0
Shanghai
Country [17] 0 0
China
State/province [17] 0 0
Taiyuan
Country [18] 0 0
China
State/province [18] 0 0
Xi'an
Country [19] 0 0
China
State/province [19] 0 0
Xianyang
Country [20] 0 0
China
State/province [20] 0 0
Zhangzhou
Country [21] 0 0
China
State/province [21] 0 0
Zhuhai
Country [22] 0 0
China
State/province [22] 0 0
Zhumadian
Country [23] 0 0
Denmark
State/province [23] 0 0
Copenhagen
Country [24] 0 0
Finland
State/province [24] 0 0
Turku
Country [25] 0 0
France
State/province [25] 0 0
Besançon
Country [26] 0 0
France
State/province [26] 0 0
Bordeaux
Country [27] 0 0
France
State/province [27] 0 0
Brest
Country [28] 0 0
France
State/province [28] 0 0
Bron
Country [29] 0 0
France
State/province [29] 0 0
Caen
Country [30] 0 0
France
State/province [30] 0 0
Clermont-Ferrand
Country [31] 0 0
France
State/province [31] 0 0
Dijon
Country [32] 0 0
France
State/province [32] 0 0
Le Kremlin-Bicêtre
Country [33] 0 0
France
State/province [33] 0 0
Limoges
Country [34] 0 0
France
State/province [34] 0 0
Marseille
Country [35] 0 0
France
State/province [35] 0 0
Montpellier
Country [36] 0 0
France
State/province [36] 0 0
Nancy
Country [37] 0 0
France
State/province [37] 0 0
Nantes
Country [38] 0 0
France
State/province [38] 0 0
Paris
Country [39] 0 0
France
State/province [39] 0 0
Reims
Country [40] 0 0
France
State/province [40] 0 0
Rouen
Country [41] 0 0
France
State/province [41] 0 0
Toulouse
Country [42] 0 0
France
State/province [42] 0 0
Tours
Country [43] 0 0
France
State/province [43] 0 0
Vannes
Country [44] 0 0
Germany
State/province [44] 0 0
Augsburg
Country [45] 0 0
Germany
State/province [45] 0 0
Berlin
Country [46] 0 0
Germany
State/province [46] 0 0
Bochum
Country [47] 0 0
Germany
State/province [47] 0 0
Erfurt
Country [48] 0 0
Germany
State/province [48] 0 0
Erlangen
Country [49] 0 0
Germany
State/province [49] 0 0
Essen
Country [50] 0 0
Germany
State/province [50] 0 0
Freiburg
Country [51] 0 0
Germany
State/province [51] 0 0
Hamburg
Country [52] 0 0
Germany
State/province [52] 0 0
Heidelberg
Country [53] 0 0
Germany
State/province [53] 0 0
Munich
Country [54] 0 0
Germany
State/province [54] 0 0
Nürnberg
Country [55] 0 0
Greece
State/province [55] 0 0
Athen
Country [56] 0 0
Hong Kong
State/province [56] 0 0
Hong Kong
Country [57] 0 0
Hungary
State/province [57] 0 0
Budapest
Country [58] 0 0
Israel
State/province [58] 0 0
Jerusalem
Country [59] 0 0
Israel
State/province [59] 0 0
Ramat Gan
Country [60] 0 0
Italy
State/province [60] 0 0
Firenze
Country [61] 0 0
Italy
State/province [61] 0 0
Milano
Country [62] 0 0
Italy
State/province [62] 0 0
Milan
Country [63] 0 0
Korea, Republic of
State/province [63] 0 0
Daejeon
Country [64] 0 0
Korea, Republic of
State/province [64] 0 0
Gwangju
Country [65] 0 0
Korea, Republic of
State/province [65] 0 0
Jeonju
Country [66] 0 0
Korea, Republic of
State/province [66] 0 0
Seoul
Country [67] 0 0
Korea, Republic of
State/province [67] 0 0
Suwon
Country [68] 0 0
Korea, Republic of
State/province [68] 0 0
Ulsan
Country [69] 0 0
Poland
State/province [69] 0 0
Warszawa
Country [70] 0 0
Portugal
State/province [70] 0 0
Vila Nova de Gaia
Country [71] 0 0
Russian Federation
State/province [71] 0 0
Novosibirsk
Country [72] 0 0
Russian Federation
State/province [72] 0 0
St. Petersburg
Country [73] 0 0
Slovakia
State/province [73] 0 0
Bratislava
Country [74] 0 0
South Africa
State/province [74] 0 0
Johannesburg
Country [75] 0 0
Spain
State/province [75] 0 0
Barakaldo
Country [76] 0 0
Spain
State/province [76] 0 0
Barcelona
Country [77] 0 0
Spain
State/province [77] 0 0
Madrid
Country [78] 0 0
Spain
State/province [78] 0 0
Oviedo
Country [79] 0 0
Spain
State/province [79] 0 0
San Sebastián
Country [80] 0 0
Spain
State/province [80] 0 0
Sevilla
Country [81] 0 0
Spain
State/province [81] 0 0
Valladolid
Country [82] 0 0
Spain
State/province [82] 0 0
Vigo
Country [83] 0 0
Switzerland
State/province [83] 0 0
Basel
Country [84] 0 0
Switzerland
State/province [84] 0 0
Bern
Country [85] 0 0
Switzerland
State/province [85] 0 0
Geneve
Country [86] 0 0
United Arab Emirates
State/province [86] 0 0
Abu Dhabi
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Birmingham
Country [88] 0 0
United Kingdom
State/province [88] 0 0
London
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Romford
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Stoke on Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Neurovascular Clinical Affairs
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medtronic Bakken Research Center
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus Holtmannspotter, MD
Address 0 0
Klinikum Nürnberg Süd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Wouter Fabry
Address 0 0
Country 0 0
Phone 0 0
+32496165078
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only multi center data will be available


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02988128