REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®

NCT ID: NCT04479020

Last Updated: 2024-12-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

134 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2024-05-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Any patient treated with the APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA) according to IFU
* Age ≥ 18 years

Exclusion Criteria

* pre stroke mRS ≥ 3
* Any contraindication according to IFU
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acandis GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Schlosspark Klinik Charlottenburg

Berlin, , Germany

Site Status

Universitätsklinikum Bonn

Bonn, , Germany

Site Status

Universitätsklinikum Köln

Cologne, , Germany

Site Status

Universitätsklinikum Düsseldorf

Düsseldorf, , Germany

Site Status

Klinikum Fulda gAG

Fulda, , Germany

Site Status

Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status

Universitätsklinikum des Saarlandes

Homburg, , Germany

Site Status

Universitätsklinikum Magdeburg A. ö. R.

Magdeburg, , Germany

Site Status

Johannes Wesling Klinikum Minden

Minden, , Germany

Site Status

Klinikum der Universität München

München, , Germany

Site Status

radprax Neurozentrum Solingen

Solingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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REVISAR Revision 4.0

Identifier Type: -

Identifier Source: org_study_id