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The purpose of the REVISAR PMCF is to collect data in clinical practice of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device, which are intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Recanalization status will be assessed at the end of the procedure using the modified TICI (Thrombolysis in cerebral infarction) score.
Study Type: prospective, multicenter, single-arm, open-label, national
Participants: 11 participating centers in Germany
PI: Dr. Franziska Dorn, University Hospital Bonn, Germany
Estimated Enrolment: A minimum of 130 patients treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to thrombotic occlusions in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)
Follow up: 3 months
Estimated Final Assessment: End of 2022
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® and APERIO® Hybrid(17) Thrombectomy Device in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA). Aperio® and Aperio® Hybrid(17) Thrombectomy Device will be used within its approved indication.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Thrombectomy | Device | Mechanical thrombectomy requiring the use an APERIO® or APERIO® Hybrid(17) Thrombectomy device due to an thrombotic occlusion in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA) |
| Measure | Description | Time Frame |
|---|---|---|
| Primary efficacy endpoint | Successful arterial recanalization of occluded target vessel measured by mTICI score of 2b or 3 following the use of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes per Device mTICI describes the response of thrombolytic therapy in ischemic stroke. Higashida et al. 2003: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion | Immediatley after interventional procedure |
| Primary safety endpoint | • Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (<48 hours) CT associated with worsening of NIHSS by ≥ 4 points within 48 hours. | 48 hours |
| Primary safety endpoint | Rates of device and procedure related (serious) adverse events ((S)AEs) | 90 days |
| Primary Safety endpoint | Mortality | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Good neurological outcome | mRS (modified Ranking Scale)= 0-2 0 No Symptoms
|
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated with an APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to a thrombotic occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schlosspark Klinik Charlottenburg | Berlin | Germany | ||||
| Universitätsklinikum Bonn |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 90 days |
| Bonn |
| 53127 |
| Germany |
| Universitätsklinikum Köln | Cologne | Germany |
| Universitätsklinikum Düsseldorf | Düsseldorf | Germany |
| Klinikum Fulda gAG | Fulda | Germany |
| Universitätsmedizin Göttingen | Göttingen | Germany |
| Universitätsklinikum des Saarlandes | Homburg | Germany |
| Universitätsklinikum Magdeburg A. ö. R. | Magdeburg | Germany |
| Johannes Wesling Klinikum Minden | Minden | Germany |
| Klinikum der Universität München | München | 80336 | Germany |
| radprax Neurozentrum Solingen | Solingen | 42697 | Germany |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |