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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.
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
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Cerebrovascular events until hospital discharge: |
|
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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:
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Patients diagnosed with acute large vessel occlusion (stroke) treated with the APERIO® Hybrid(17/21) Thrombectomy Device.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evangelisches Krankenhaus Oldenburg | Oldenburg | 26122 | Germany |
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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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| between 24 hours after intervention and discharge from hospital |
| Cerebrovascular events at 90 days |
| at 90 days |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |