A Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke
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|ClinicalTrials.gov Identifier: NCT03957278|
Recruitment Status : Suspended (Device modifications)
First Posted : May 21, 2019
Last Update Posted : June 17, 2020
|Condition or disease||Intervention/treatment||Phase|
|Stroke, Acute||Device: DAISe System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm, multi-center, prospective study where all eligible subjects are treated with the study device after enrollment.|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multi-Center, Single Arm Study to Evaluate the DAISe System During Neurointervention for Acute Ischemic Stroke|
|Actual Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||December 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: DAISe System
The DAISe System consists of the DAISe thrombectomy device used in with the Q Aspiration Catheter.
Device: DAISe System
The DAISe System is indicated for revascularization of patients with acute ischemic stroke for the removal of fresh thrombi from vessels in the neurovasculature.
- Number of participants with successful revascularization [ Time Frame: intra-procedural ]Defined as mTICI 2b-3 flow in the target vessel post-treatment of up to three passes with the DAISe System.
- Rate of symptomatic intracranial haemorrhage [ Time Frame: 12-36 hours post procedure ]24 hours post-procedure as detected by CT/MRI with an NIHSS change of >4
- Number of participants with successful revascularization of mTICI 2b-3 as a result of the first attempt with the DAISe System [ Time Frame: intra-procedural ]
- Number of participants with successful revascularization of mTICI 3 as a result of the first attempt with the DAISe System [ Time Frame: intra-procedural ]
- Number of participants with successful revascularization of final mTICI 2b-3 at the end of the procedure [ Time Frame: intra-procedural ]
- Time from groin puncture to successful revascularization defined as final mTICI 2b-3 flow [ Time Frame: intra-procedural ]
- Rate of procedure-related complications [ Time Frame: post procedure through discharge ]
- Rate of embolization to a new vascular territory (ENT) [ Time Frame: intra-procedural ]
- Good functional outcome for participants measured by Modified Rankin Scale score of 0-2. [ Time Frame: 30 days and 3 months post procedure ]The Modified Rankin Scale (mRS) measures neurological disability or dependence for stroke patients on a scale of 0 (no symptoms) to 6 (deceased).
- Quality of life for participants: PROMIS Scale [ Time Frame: 3 months post procedure ]PROMIS Scale
- Rate of all cause mortality [ Time Frame: 30 days and 3 months post procedure ]
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): NCT03957278
|Brussels, Belgium, 1070|
|Hospital Civil Marie Curie|
|Charleroi, Belgium, 140|