APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke
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ClinicalTrials.gov Identifier: NCT04457479 |
Recruitment Status :
Recruiting
First Posted : July 7, 2020
Last Update Posted : October 15, 2021
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Condition or disease |
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Acute Stroke |
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: 13 participating centers in Germany planned
PI: Dr. Christian Mathys, Evangelisches Krankenhaus Oldenburg, Germany
Estimated Enrolment: 430 patients treated with APERIO® HYBRID Thrombectomy
Device as a result of an acute stroke
Follow up: 3 months
Estimated Final Assessment: End of 2022
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 430 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Months |
Official Title: | APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke |
Actual Study Start Date : | November 2, 2020 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | January 2023 |

- Technical success [ Time Frame: until 24 hours after intervention ]mTICI ≥ 2b APERIO® HYBRID
- Good clinical outcome at 90 days [ Time Frame: 90 days after intervention ]Modified Rankin Scale (mRS) < 3 (mRS 1= no symptoms/ good outcome; mRS 6= Patient died/ worse outcome)
- Periprocural symptomatic intracranial hemorrhage (sICH): [ Time Frame: until 24 hours after intervention ]ICH in postinterventional (<24 hours) CT associated with worsening of NIHSS by ≥ 4 points within 24 hours
- Cerebrovascular events until hospital discharge: [ Time Frame: between 24 hours after intervention and discharge from hospital ]
- 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
- Cerebrovascular events at 90 days [ Time Frame: at 90 days ]
- Intracranial haemorrhage (symptomatic / asymptomatic)
- Death
- TIA
- Non-disabling ischemic stroke (MRS 0-2)

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- All patients treated with APERIO® HYBRID and/or APERIO® Hybrid(17) Thrombectomy Device as a result of an acute stroke.
Exclusion Criteria:
- Patient age < 18 years
- Pre stroke mRS ≥ 3

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04457479
Contact: Christian Mathys, Dr. | +49 441 236 236 | radiologie@evangelischeskrankenhaus.de |
Germany | |
Evangelisches Krankenhaus Oldenburg | Recruiting |
Oldenburg, Germany, 26122 | |
Contact: Christian Mathys, Dr. +49 441 236 236 | |
Principal Investigator: Christian Mathys, Dr. |
Responsible Party: | Acandis GmbH |
ClinicalTrials.gov Identifier: | NCT04457479 |
Other Study ID Numbers: |
HYBRID |
First Posted: | July 7, 2020 Key Record Dates |
Last Update Posted: | October 15, 2021 |
Last Verified: | October 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Stroke Ischemic Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |