Clotild® Smart Guidewire System Evaluation in Endovascular Thrombectomy Procedure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- The Proportion of Patients Having Intracranial Vessel Perforation and / or Dissection Due to Clotild® Usage at the Site of Usage in Intracranial Vessels
研究概览
简要总结
The purpose of this First-in-Human study is to evaluate the safety of using the Clotild® system to guide the endovascular thrombectomy (EVT) device to the clot location during EVT for the treatment of an acute ischemic stroke eligible to EVT, whatever the EVT device chosen. A secondary purpose is to assess the clinical performance, defined as the feasibility of measuring clot electrophysiological parameters in vivo during EVT procedures.
详细描述
Clotild® is a neurovascular guidewire equipped with the Sensome proprietary impedance sensor. The latter allows the measurement of the electrophysiological characteristics of the surrounding tissues. Clotild® could categorize the thrombus occluding the cerebral blood vessel, and support the neurointerventionist during mechanical thrombectomy for the treatment of ischemic stroke. The aim of the study is to evaluate the safety and the performance of the device. The electrophysiological measurements will be used to update Clotild®'s database and thus improve the prediction accuracy of the model in providing physicians with insights for mechanical thrombectomy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical signs and symptoms consistent with the diagnosis of an acute ischemic stroke eligible for EVT
- •M1 and/or MCA bifurcation arterial occlusion on Computed tomography angiography (CTA) or MRA (Magnetic resonance angiography) of an intracranial vessel amenable to EVT
- •Informed Consent by subject, subject's Legally Authorized Representative (LAR) or anyone approved by the Ethics Committee (EC) and/or regulatory agencies to provide consent on behalf of the subject.
排除标准
- •Patient having an intracranial occlusion other than M1 and/or MCA bifurcation, especially tandem occlusion and ICA (internal carotid artery) occlusion.
- •Current participation in another investigational device or drug study that has not completed the primary endpoint or that clinically interferes with the current study endpoints
- •Candidates not eligible for EVT based on neurointerventionist and/or neurologist investigators' opinion
- •Pregnancy or lactating subjects
研究组 & 干预措施
Clotild®
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 42 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. Clots will be retrieved and analysed in a group of participants for which Clotild® is used as neurovascular guidewire.
干预措施: Clotild® Smart Guidewire System (CSGS) (Device)
结局指标
主要结局
The Proportion of Patients Having Intracranial Vessel Perforation and / or Dissection Due to Clotild® Usage at the Site of Usage in Intracranial Vessels
时间窗: Measured during the procedure and up to 24hr follow-up (when the 24hr images are taken)
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 by Distinguishing Local Regions With Substantial Versus Negligible RBC Content in the Occlusion
时间窗: Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)
* The performance of the CSGS model will be assessed by the performance metric Area Under the Receiver Operator Characteristic curve (AUC of ROC) computed from the RBC-content score predicted on the validation dataset only. * The ROC curve will be defined by the sensitivity (true positive rate) on the Y-axis and 1- specificity (false positive rate) on the X-axis. The ground truth is defined as the binary classification of the local regions into RBC-positive or RBC-negative content performed by SENSOME experts. * The comparator will be the binary classification score determined by the CSGS model. The CSGS model will be developed using interventions from the development phase (Development Performance Population) while it will be validated on the impedance data from the validation phase (Local-Scale Performance Population).
次要结局
- 1. The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology (i.e., Histopathology) Results of the Clot Retrieved During the EVT Procedure, Regarding Red Blood Cell Content in the Occlusion,(Occlusion Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject). Clot retrieved few minutes after study procedure ended.)
- 2. The Ability of CSGS to Detect the Proximal End of the Occlusion (Sensor-scale), as Compared to the Physician's Labelling (Tag 'PRE CLOT' for no Occlusion Contact and Tag 'CLOT' for Occlusion Contact),(Measurements taken by the investigator during the first few minutes of the study procedure)
- 3. Procedural Success Defined as the Ability to Navigate CSGS to the Occlusion Site and Measure Electrophysiological Properties of the Occlusion,(Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)
- 4. The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements (Local-scale) by Distinguishing Local Regions With Substantial Platelet Content From Regions With Negligible Platelet Content in the Occlusion,(Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject)
- 5. The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology Results of the Clot Retrieved During the EVT Procedure, Regarding Platelet Content in the Occlusion,(Occlusion Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject). Clot retrieved few minutes after study procedure ended.)
- 6. The Ability to Perform Binary Classification of Individual Electrophysiological Parameter Measurements (Local-scale) by Distinguishing Local Regions With Substantial Fibrin Content From Regions With Negligible Fibrin Content in the Occlusion,(Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject))
- 7. The Concordance Between Aggregated Occlusion Measurements (Clot-scale) Done by CSGS, and the Histology Results of the Clot Retrieved During the EVT Procedure, Regarding Fibrin Content in the Occlusion.(Occlusion Measurements taken by the investigator during the study procedure (insertion of the study device till removal from subject). Clot retrieved few minutes after study procedure ended.)