Clotild® Smart Guidewire System (CSGS) Evaluation in EndovascUlar Thrombectomy Procedure (CLOTOUT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04993079|
Recruitment Status : Recruiting
First Posted : August 6, 2021
Last Update Posted : April 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Stroke||Device: Clotild®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure|
|Actual Study Start Date :||August 26, 2021|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||August 30, 2022|
Subjects presenting an acute ischemic stroke due to M1 or middle cerebral artery (MCA) bifurcation occlusion, eligible for Endovascular Thrombectomy (EVT) based on neuro-interventionist and/or neurologist investigators' opinion will be eligible. Twenty (20) patients will be initially enrolled. Up to 100 patients will be enrolled following an analysis of the data of the first 20 enrolled patients by a data safety monitoring board (DSMB) and its' recommendation to proceed with the study.
Sixty clots will be retrieved and analysed in a group of participants for which Clotild® is used as neurovascular guidewire.
Use of Clotild® as neurovascular guidewire
- The proportion of patients having intracranial vessel perforation and / or dissection due to Clotild® usage at the site of usage in intracranial vessels [ Time Frame: Measured during the procedure ]Tthe proportion of patients having intracranial vessel perforation and / or dissection due to Clotild® usage at the site of usage in intracranial vessels will be assessed by Interventional Neuroradiologist during the procedure and final adjudication of the DSA (Digital Subtraction Angiography) by the Data Safety Monitoring Board.
- The ability to perform binary classification of individual electrophysiological parameter measurements [ Time Frame: Measured during the procedure ]The ability to perform binary classification of individual electrophysiological parameter measurements will be assessed by distinguishing local regions with substantial red blood cell content (RBC-rich) from regions with negligible red blood cell content (RBC-poor) in the occlusion.
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): NCT04993079
|Contact: Hans Tielemans||+33 1 85 37 07 firstname.lastname@example.org|
|Contact: Franz Bozsak||+33 1 85 37 07 email@example.com|
|Australia, New South Wales|
|Liverpool, New South Wales, Australia, NSW 2170|
|Contact: Dennis Cordato|
|Royal Brisbane and Women's Hospital||Not yet recruiting|
|Herston, Queensland, Australia, QLD 4029|
|Contact: Alan Coulthard|
|Gold Coast University Hospital||Recruiting|
|Southport, Queensland, Australia, QL 5215|
|Contact: Hal Rice|
|Principal Investigator:||Andrew Cheung, MD||Liverpool Hospital, Liverpool NSW, Australia|
|Principal Investigator:||Dennis Cordato, MD||Liverpool Hospital, Liverpool NSW, Australia|