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.
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
Study Type
OBSERVATIONAL
Enrollment
190
Evangelisches Krankenhaus Oldenburg
Oldenburg, Germany
Technical success
mTICI ≥ 2b after treatment with APERIO® HYBRID(17/21)
Time frame: 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)
Time frame: 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
Time frame: until 24 hours after intervention
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
Time frame: 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)
Time frame: at 90 days
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