A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific
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|ClinicalTrials.gov Identifier: NCT06042335|
Recruitment Status : Not yet recruiting
First Posted : September 18, 2023
Last Update Posted : September 18, 2023
|Condition or disease||Intervention/treatment||Phase|
|Acute Ischemic Stroke||Device: DAISe EZ||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Feasibility Study for the DAISe EZ Thrombectomy Device - Pacific|
|Estimated Study Start Date :||December 2023|
|Estimated Primary Completion Date :||April 2024|
|Estimated Study Completion Date :||July 2024|
Experimental: DAISe EZ
Mechanical thrombectomy utilizing the DAISe Thrombectomy System, consisting of the DAISe Thrombectomy Device and DAISe Delivery Catheter, used with aspiration.
Device: DAISe EZ
DAISe Thrombectomy System for mechanical thrombectomy
- Successful revascularization [ Time Frame: Procedure ]Defined as proportion of subjects with mTICI 2b-3 flow post treatment with the DAISe Thrombectomy Device.
- Symptomatic intracranial hemorrhage (sICH) at 24 hours post-procedure [ Time Frame: 12-36 hours ]Defined as proportion of subjects with Symptomatic intracranial haemorrhage (sICH) at 24 hours post-procedure as detected by CT/MRI with clinical deterioration of an NIHSS change of greater than or equal to 4.
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): NCT06042335
|Contact: Stephanie Cihlarfirstname.lastname@example.org|