Prospective, Multicentre Study to Evaluate the Thrombectomy System for Stroke: INEDIT, INDEEP and INTERCEPT

Study Overview
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Brief Summary
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First prospective, single-arm, multicentre study to evaluate the safety and efficacy of the overall stroke thrombectomy system: INEDIT, INDEEP and INTERCEPT in patients with acute ischemic stroke.

Detailed Description
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This is a prospective, multicentre, single-arm and open-label clinical safety and efficacy research. The purpose of the study is to evaluate the safety and efficacy of the three devices designed by iVascular for neurothrombectomy (iNedit, iNdeep and iNtercept) used together as a tool to facilitate the placement of the stent retriever and apply temporary restriction of blood flow in patients who have suffered a stroke and who undergo mechanical thrombectomy due to acute large vessel occlusion (LVO), presented within 8 hours from symptoms onset (the last time the patient was seen well). Being a mechanical thrombectomy the procedure by which the thrombus that occludes a cerebral vessel is accessed. It is accessed through an endovascular catheter, inserted through the femoral artery, for disruption or removal.

Official Title
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First Prospective, Single-arm, Multicentre Study to Evaluate the Safety and Efficacy of the Overall Thrombectomy System for Stroke: INEDIT, INDEEP and INTERCEPT in Patients With Acute Ischemic Stroke.

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Device: iNedit, iNdeep, iNtercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical: Age ≥18 Informed consent signed by the patient or their representative; to use the patient's data Focal disabling neurologic deficit consistent with acute cerebral ischemia. Baseline NIHSS obtained before procedure of ≥6 points and ≤25 points. Pre-stroke mRS score ≤2. Planning to start treatment within 8 hours of symptoms onset, defined as the last time when the patient was seen well (the start of the procedure is defined as arterial puncture). Neuroimaging criteria: Occlusion (TICI 0 or TICI 1) of the internal intracranial carotid artery, M1 and M2 segments of the middle cerebral artery and T carotid artery, suitable for mechanical thrombectomy confirmed by conventional angiography. For patients treated ≤8 hours: a) Score 6 to 10 on ASPECTS scale (Alberta Stroke Program Early CT Score). For patients treated between 8 and 24 hours: a) Target Mismatch Profile on CT perfusion or MRI (ischemic core volume is <70mL, mismatch ratio is >1,8 and mismatch volume is >15 mL). Ability to obtain selective angiography by catheterisation of the target artery. Exclusion Criteria: Clinical: Initially treated with a different thrombectomy device in the same procedure. Patient has suffered a stroke in the past one year. Occlusion (TICI 0 or TICI 1) in vertebrobasilar territory. Clinical symptoms suggestive of bilateral stroke or stroke in multiple territories. Known hemorrhagic diathesis, coagulaion factor deficiency or oral anti-vitamin K anticoagulant therapy with an INR >3.0. Blood glucose <50 mg/dl or >400 mg/dl. NOTE: If blood glucose can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines, the patient may be included. Severe sustained hypertension (systolic pressure >185 mm Hg or diastolic pressure >110 mm Hg). NOTE: If blood pressure can be successfully reduced and maintained at an acceptable level by administering the medication recommended by the ESO (European Stroke Organisation) in its guidelines (also IV infusion of antihypertensives), the patient may be included. Serious advanced or terminal illness with anticipated life expectancy of less than six months. History of life-threatening allergy (more than rash) to contrast medium. Known allergy to nickel, prior to treatment. Known renal insufficiency with creatinine ≥3 mg/dl or Glomerular Filtration Rate (GFR) <30 mL/min. Cerebral vasculitis. Known current cocaine use. Patient who is participating, at the time of inclusion, in a study with a device or drug that could affect this study. Patients who are unlikely to be available for 90-day follow-up (e.g. no fixed home address, visitors from overseas). Neuroimaging criteria: CT or MRI evidence of hemorrhage (the presence of microbleeds is allowed). Significant mass effect with midline shift. Evidence of complete occlusion, high-grade stenosis or arterial dissection in the extracranial or petrous segment of the internal carotid artery (TANDEM lesions). Patients with known or suspected underlying intracranial atherosclerotic lesions responsible for the target occlusion. Patients with occlusions in multiple vascular territories (e.g. bilateral anterior circulation or anterior/posterior circulation). Evidence of intracranial tumour with the exception of asymptomatic meningiomas with no mass effect. Presumed septic embolism with suspected aortic dissection or suspicion of bacterial endocarditis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iNedit, iNdeep, iNtercept<br>Study devices | Device: iNedit, iNdeep, iNtercept<br>* Patients to undergo mechanical thrombectomy with iNedit, iNdeep and iNtercept<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Success | To assess the ability of the system to successfully perform a neurothrombectomy using the three devices to be evaluated and with ≤3 insertions (passes) of the stent retriever. | In the course of endovascular procedure, evaluated immediately after it. | 
| MAE | All serious adverse events following the intervention or until an alternative stroke treatment is started, whichever occurs first. | 24 hours (-8/+12 h) | 
| Mortality | All-cause mortality | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical progress | Good functional clinical progress (modified Rankin scale 0-2) | 90 days | 
| Proportion of patients with rapid neurological improvement | Proportion of patients with rapid neurological improvement (more than 4 points on the NIHSS scale, or NIHSS ≤4) | 24 hours after treatment | 
| Reduction of NIHSS scale | Proportion of patients with a reduction of ≥8 points on the NIHSS scale or NIHSS 0-1 | At 72 hours or at the time of discharge, whichever occurs first. | 
| Procedure duration | Procedure duration defined as the time from puncture to when grade ≥2b is reached on the mTICI scale with less than three passes or, if not achieved, until the final angiogram. | In the course of endovascular procedure, evaluated immediately after it. | 
| Number of passes with the device until recanalization. | Number of passes with the device until recanalization. | In the course of endovascular procedure, evaluated immediately after it. | 
| Percentage of effective recanalization in a first pass. | Percentage of effective recanalization in a first pass. | In the course of endovascular procedure, evaluated immediately after it. | 
| Rate of cases that reached the occlusion and allowed the performance of the trombectomy. | Rate of cases where the microcatheter and the distal access balloon catheter reached the occlusion in the main vessel to allow navigation and deployment of the stent retriever to carry out the neurothrombectomy. | In the course of endovascular procedure, evaluated immediately after it. | 
| Assessment of intracranial haemorrhage (ICH) | Assessment of intracranial haemorrhage (ICH); any symptomatic or asymptomatic intracranial haemorrhage assessed by magnetic resonance imaging (MRI) /computed tomography (CT). | 24 (-8/+12) hours | 
| Neurological deterioration | Classification of neurological deterioration of ≥4 points on the NIHSS scale | 24 (-8/+12) hours. | 
| Embolization rate | Embolization rate in a previously non-involved territory on cerebral angiography. | In the course of endovascular procedure, evaluated immediately after it. | 
| Mortality rate | Mortality rate related to the procedure | 3 days (+/-24) hours | 
| Procedure complication rate | Procedure complication rate: arterial perforation, arterial dissection and vasospasm in the target vessel and embolization in a previously non-involved vascular territory. | In the course of endovascular procedure, evaluated immediately after it. | 
| Rate of infarction in a previously non-involved vascular territory | Rate of infarction in a previously non-involved vascular territory, as evaluated by imaging (MRI/CT). | 24 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Mechanical Neurothrombectomy, Ischemia