APERIO® HYBRID Thrombectomy Device for Flow Restoration in Vessels of Patients Experiencing Acute Ischemic Stroke

NCT ID: NCT04457479

Last Updated: 2023-08-14

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

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-02

Study Completion Date

2023-06-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Acute Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

* Patient age \< 18 years
* Pre stroke mRS ≥ 3
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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Evangelisches Krankenhaus Oldenburg

Oldenburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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HYBRID

Identifier Type: -

Identifier Source: org_study_id

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