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

Acandis

Status: Completed

Conditions: Acute Stroke

Study type: Observational

Funder types: Industry

Identifiers

NCT04457479

HYBRID

Details and patient eligibility

About

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.

Full description

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

Enrollment: 190 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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