Analysis of Revascularisation in Ischemic Stroke With EmboTrap (ARISE)
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|ClinicalTrials.gov Identifier: NCT02190552|
Recruitment Status : Active, not recruiting
First Posted : July 15, 2014
Last Update Posted : September 13, 2017
|Condition or disease||Intervention/treatment|
|Ischemic Stroke||Device: EmboTrap® Revascularization Device|
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||A.R.I.S.E. Analysis of Revascularisation in Ischemic Stroke With EmboTrap: Post Marketing Observational Study of CE Marked EmboTrap Mechanical Thrombectomy Device|
|Actual Study Start Date :||November 2014|
|Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||December 2017|
EmboTrap® Revascularization Device
The EmboTrap® Revascularization Device is the investigational device
Device: EmboTrap® Revascularization Device
Other Name: EmboTrap
- Revascularisation as measured by modified Thrombolysis in Cerebrovascular Infarction (mTICI with 2c) score of at least 2b following the use of the Neuravi device. [ Time Frame: Day 1 ]
- Time to Revascularization [ Time Frame: Day 1 ]Defined as time from groin puncture to visualization of final angiographic result.
- Mortality post procedure [ Time Frame: 7 and 90(±14) days post procedure ]All procedure related mortality (i.e. directly traceable to a procedure related SAE).
- Serious Adverse Device related effects (SADE) [ Time Frame: 24(-8/+12) hours Post Procedure ]SADE is defined as vessel perforation or vessel dissection, which is attributable to the Neuravi device, or where the Neuravi device cannot be ruled out as the cause.
- Symptomatic ICH [ Time Frame: 24(-8/+12) hours Post Procedure ]Symptomatic ICH rate within 24 hours (range: 16 to 36 hours) post-procedure. Symptomatic intracranial haemorrhage (parenchymatous haemorrhage type 2), at post-treatment scan combined with neurological deterioration (C2) leading to an increase of 4 points or more on the NIH Stroke Scale.
- Clinical outcome at 90 days [ Time Frame: 90(±14) days Post Procedure ]A good clinical outcome will be judged to be a mRS score of ≤2 at 90(±14) days.
- Rate of New Territory Embolization [ Time Frame: 24(-8/+12) hours Post Procedure ]Embolization, or thrombus dislocation, into a previously uninvolved vascular territory as evaluated from angiographic images by the Angiography Core Lab and the Data Safety Monitoring Board.
- Evidence of Infarction [ Time Frame: 24(-8/+12) hours Post Procedure ]Infarction, of a previously uninvolved vascular territory, as evaluated from 24hr Computed Tomography imaging by the Angiography Core lab.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02190552
|Aarhus University Hospital|
|Hospital Clinico de Barcelona|
|Solna, Sweden, 17176|
|Principal Investigator:||Dr. Tommy Andersson||Karolinska Institutet|
|Principal Investigator:||Prof. Dr. Heinrich Mattle||University Hospital Inselspital, Berne|