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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02988128
Ethics application status
Date submitted
7/12/2016
Date registered
7/12/2016
Date last updated
9/01/2019

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

Health condition
Health condition(s) or problem(s) studied:
Intracranial Aneurysm 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

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 intracranial aneurysms
Embolization of aneurysms

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

Eligibility
Key inclusion criteria
- Patient or legally authorized representative provides written authorization and/or
consent per institution and geographical requirements

- Patient is intended to receive treatment with an eligible product

- Patient within enrollment window of treatment/therapy received at the time of their
initial enrollment.
Minimum age
No limit
Maximum age
No limit
Gender
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

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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
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
Denmark
State/province [2] 0 0
Copenhagen
Country [3] 0 0
Finland
State/province [3] 0 0
Turku
Country [4] 0 0
France
State/province [4] 0 0
Besançon
Country [5] 0 0
France
State/province [5] 0 0
Bron
Country [6] 0 0
France
State/province [6] 0 0
Le Kremlin-Bicêtre
Country [7] 0 0
France
State/province [7] 0 0
Marseille
Country [8] 0 0
France
State/province [8] 0 0
Montpellier
Country [9] 0 0
France
State/province [9] 0 0
Paris
Country [10] 0 0
France
State/province [10] 0 0
Toulouse
Country [11] 0 0
Germany
State/province [11] 0 0
Augsburg
Country [12] 0 0
Germany
State/province [12] 0 0
Berlin
Country [13] 0 0
Germany
State/province [13] 0 0
Erfurt
Country [14] 0 0
Germany
State/province [14] 0 0
Erlangen
Country [15] 0 0
Germany
State/province [15] 0 0
Essen
Country [16] 0 0
Germany
State/province [16] 0 0
Hamburg
Country [17] 0 0
Germany
State/province [17] 0 0
Heidelberg
Country [18] 0 0
Greece
State/province [18] 0 0
Athen
Country [19] 0 0
Hong Kong
State/province [19] 0 0
Hong Kong
Country [20] 0 0
Hungary
State/province [20] 0 0
Budapest
Country [21] 0 0
Israel
State/province [21] 0 0
Jerusalem
Country [22] 0 0
Israel
State/province [22] 0 0
Ramat Gan
Country [23] 0 0
Italy
State/province [23] 0 0
Firenze
Country [24] 0 0
Italy
State/province [24] 0 0
Milano
Country [25] 0 0
Russian Federation
State/province [25] 0 0
Novosibirsk
Country [26] 0 0
Slovakia
State/province [26] 0 0
Bratislava
Country [27] 0 0
South Africa
State/province [27] 0 0
Johannesburg
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Madrid
Country [30] 0 0
Spain
State/province [30] 0 0
Oviedo
Country [31] 0 0
Spain
State/province [31] 0 0
San Sebastián

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
Post market surveillance registry
Trial website
https://clinicaltrials.gov/show/NCT02988128
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Markus Holtmannspotter, MD
Address 0 0
Rigshospitalet, University of Copenhagen, Department of Neuroradiology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Antoine Cuijpers
Address 0 0
Country 0 0
Phone 0 0
+31433566831
Fax 0 0
Email 0 0
antoine.cuijpers@medtronic.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable