NCT04479020

REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 134 (actual)
• Sponsor: Acandis GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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

• Acute Stroke

Interventions

Type	Name	Description
DEVICE	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)

Timeline

• Start date: 2020-07-01
• Primary completion: 2024-01-30
• Completion: 2024-05-01
• First posted: 2020-07-21
• Last updated: 2024-12-06

Locations

11 sites across 1 country: Germany