European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke

Study Overview
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Brief Summary
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Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice.

Detailed Description
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Prospective, single-arm, multicenter, observational registry of the ACE Reperfusion Catheters and the Penumbra System in Europe. Consecutive patients presenting within 6 hours from symptom onset with an acute ischemic stroke (within the internal carotid artery and internal carotid terminus, middle cerebral - M1/M2 segments) due to anterior circulation large vessel occlusion (LVO) will be treated using the ADAPT technique with thrombo-aspiration as first intention and site routine practice. The follow-up visit will occur 24 hours, 7-10 days or discharge, 30 days and 90 days post-procedure and will review patient's functional outcome, quality of life, and adverse events.

Official Title
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A Prospective, Multicenter, Observational, Single-arm European Registry on the ACE Reperfusion Catheters and the Penumbra System in the Treatment of Acute Ischemic Stroke

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Device: Penumbra Aspiration System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General inclusion criteria: From 18 years of age Present with symptoms consistent with an acute ischemic stroke within 6 hours of stroke symptom onset Arterial occlusion of the distal intracranial carotid artery (ICA and ICA terminus) or middle cerebral artery (M1/M2) National Institute of Health Stroke Scale (NIHSS) ≥ 2 Signed Informed Consent Form. Imaging inclusion criteria: • CT ASPECT score from 6 to 10 (>6) or according to MR DWI ASPECT score from 5 to 10 (>5). Exclusion Criteria: General exclusion criteria: Associated myocardial infarction or severe infection (endocarditis or sepsis) Laboratory evidence of coagulation abnormalities, with an International Normalized Ratio (INR) of > 3.0 or platelets count < 40 x109/L or APTT > 50 sec Uncontrolled hypertension (defined as systolic blood pressure > 185 mmHg or diastolic blood pressure > 110 mmHg) Baseline glucose < 2.7 or > 22.2 mmol/L Pre-stroke mRS score > 2 Seizure at the onset of stroke Arterial tortuosity that would prevent the device from reaching the target vessel Time of stroke symptoms onset unknown Life expectancy less than 90 days prior to stroke onset Females who are pregnant or lactating Known serious sensitivity to radiographic contrast media. Imaging exclusion criteria: CT/MRI evidence of the following conditions at screening: Significant mass effect with midline shift Evidence of intracranial hemorrhage (ICH), aneurysm, or arteriovenous malformation (AVM) Angiographic evidence of tandem extracranial occlusion or an arterial stenosis proximal to the occlusion that requires treatment prior to thrombus removal. Moderate stenosis not requiring treatment is not an exclusion criterion. Angiographic evidence of preexisting arterial injury, such as carotid dissection, complete cervical carotid occlusion, or vasculitis.

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 |
| --- | --- |
| Penumbra Aspiration System<br>Penumbra Aspiration System with the ADAPT technique | Device: Penumbra Aspiration System<br>* Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiographic revascularization of the occluded target vessel at immediate post-procedure as defined by a TICI 2b or 3 score. |  | Immediate post-procedure | 
| Functional patient outcome at 90 days post-procedure as defined by a modified Rankin Score (mRS) 0-2. |  | 90 days post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of device and procedure related Serious Adverse Events (SAEs) at 24 hours and 30 days from stroke treatment |  | 24 hours and 30 days from stroke treatment | 
| All causes of mortality and morbidity at 90 days |  | 90 days | 
| Occurrence of embolization in previously uninvolved (or new) territories (ENT) as seen on the final control angiogram at the end of procedure |  | At the end of interventional surgical procedure | 
| Occurrence of symptomatic intracranial hemorrhages (sICH) at 24 hours |  | 24 hours | 
| Occurrence of vessel damages at the end of the ADAPT procedure. |  | At the end of the interventional surgical procedure | 
| NIHSS score at 7-10 days post-procedure. |  | 7-10 days post-procedure | 
| Times to revascularization | From symptom onset to CT-scan/MRI at the institution From CT-scan/MRI at the institution to groin access From groin puncture to final revascularization result. | From symptom onset to various times during the interventional surgical procedure | 
| Quality of Life: EQ-5D 3L score at 90 days compared to the one at 7-10 days post-procedure. |  | 90 days | 
| Heath Economics: Total duration of hospitalization with related healthcare resources | Health care professionals encountered/consulted before/after intervention Tests performed before/after intervention. | Average time frame 3-7 days. |