REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®
NCT ID: NCT04479020
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
134 participants
OBSERVATIONAL
2020-07-01
2024-05-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Mechanical Thrombectomy
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)
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
Exclusion Criteria
* Any contraindication according to IFU
18 Years
ALL
No
Sponsors
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Acandis GmbH
INDUSTRY
Responsible Party
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Locations
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Schlosspark Klinik Charlottenburg
Berlin, , Germany
Universitätsklinikum Bonn
Bonn, , 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, , Germany
radprax Neurozentrum Solingen
Solingen, , Germany
Countries
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Other Identifiers
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REVISAR Revision 4.0
Identifier Type: -
Identifier Source: org_study_id