Clinical Studies

Mechanical Thrombectomy

Mechanical thrombectomy is a well-known and commonly practiced therapy for treatment of acute ischemic stroke. The therapy aims to remove a clot to recanalise an occluded vessel. Mechanical thrombectomy can be performed as single aspiration or in combination with a stent retriever. Many trials deal with the different methods of mechanical thrombectomy and devices available in the marked.
Further investigations consider new devices and/or applications like distal thrombectomy. Clinical data are necessary to analyse safety and efficacy of the therapy in new territories and the devices, which are suitable and recommended for those cases.
The APERIO® REVISAR and APERIO® HYBRID PMCF studies evaluate the safety and efficacy of Acandis® thrombectomy devices according to their intended use and under clinical treatment routine.

APERIO® REVISAR (PMCF)

REcanalization of Distal cerebral Vessels In Acute Stroke using ApeRio® - REVISAR

PI:
Dr. Franziska Dorn, University Hospital Bonn, Germany
Sponsor: ACANDIS GmbH, Pforzheim, Germany
Device: APERIO® Thrombectomy Device/ APERIO® Hybrid Thrombectomy Device/ APERIO® Hybrid17 Thrombectomy Device
Clinical trials.gov identifier: NCT04479020
Study Type: Prospective, one-armed, open-label, multicentre, national
Objective:
The evaluation of the safety and efficacy of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device in artery occlusions in the anterior and posterior circulation with a vessel diameter < 3 mm
(Est.) Enrolment: 130 patients
Status: Active, enroling

 

APERIO® HYBRID (PMCF)

APERIO® HYBRID Thrombectomy device for flow restoration in vessels of patients experiencing acute ischemic stroke  - HYBRID

PI:
Dr. Christian Mathys, Evangelisches Krankenhaus Oldenburg, Germany
Sponsor: ACANDIS GmbH, Pforzheim, Germany
Device: APERIO® Hybrid Thrombectomy Device/ APERIO® Hybrid17 Thrombectomy Device
Clinical trials.gov identifier: NCT04457479
Study Type: Prospective, one-armed, open-label, multicentre, national
Objective:
The investigation of potential residual risks associated with the use of the device and to update the clinical evaluation of the device in order to ensure the long-term safety and performance of the APERIO® Hybrid(17)  Thrombectomy Device after its placing on the market

(Est.) Enrolment: 430 patients
Status: Active, enroling