APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke

Study Overview
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Brief Summary
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This is a prospective, multicenter, single-arm, open-label, national Post-Market Clinical Follow-up study to collect comprehensive information on technical and clinical success and safety of the use of APERIO® Hybrid(17/21) Thrombectomy Device in clinical practice. APERIO® Hybrid(17/21) Thrombectomy Device will be used within its approved indication.

Detailed Description
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German APERIO® Hybrid Post- Market Clinical Follow-up Study APERIO® Hybrid PMCF Study- Thrombectomy device for flow restoration in vessels of patients experiencing acute ischemic stroke Study Type: prospective, multicenter, single-armed, open-label Participants: 8 participating centers in Germany PI: Dr. Christian Mathys, Evangelisches Krankenhaus Oldenburg, Germany Estimated Enrolment: 190 patients treated with APERIO® HYBRID(17/21) Thrombectomy Device as a result of an acute stroke Follow up: 3 months Estimated Final Assessment: Mid to End of 2023

Official Title
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APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke

Conditions
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Acute Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - All patients treated with APERIO® HYBRID and/or APERIO® Hybrid(17/21) Thrombectomy Device as a result of an acute stroke. Exclusion Criteria: Patient age < 18 years Pre stroke mRS ≥ 3

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success | mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21) | until 24 hours after intervention | 
| Good clinical outcome at 90 days | Modified Rankin Scale (mRS) < 3 (mRS 1= no symptoms/ good outcome; mRS 6= Patient died/ worse outcome) | 90 days after intervention | 
| Periprocural symptomatic intracranial hemorrhage (sICH): | ICH in postinterventional (<24 hours) CT associated with worsening of NIHSS by ≥ 4 points within 24 hours | until 24 hours after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerebrovascular events until hospital discharge: | Intracranial haemorrhage (symptomatic / asymptomatic) Death TIA in the region of the target vessel Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel Disabling ischemic stroke (MRS 3-6) in the region of the target vessel TIA outside the region of the target vessel Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel | between 24 hours after intervention and discharge from hospital | 
| Cerebrovascular events at 90 days | Intracranial haemorrhage (symptomatic / asymptomatic) Death TIA Non-disabling ischemic stroke (MRS 0-2) Disabling ischemic stroke (MRS 3-6) | at 90 days |