REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®

Completed

• Conditions: Acute Stroke

• Registration Number: NCT04479020
• Lead Sponsor: Acandis GmbH

Brief 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.

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-07-02
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-21
• Primary Completion: 2024-01-30
• Study Completion: 2024-05-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety endpoint	90 days	Mortality
Primary safety endpoint	90 days	Rates of device and procedure related (serious) adverse events ((S)AEs)
Primary efficacy endpoint	Immediatley after interventional procedure	Successful arterial recanalization of occluded target vessel measured by mTICI score of 2b or 3 following the use of the APERIO® and APERIO® Hybrid(17) Thrombectomy Device without any symptomatic intracranial hemorrhage and rescue therapy within 3 passes per Device mTICI describes the response of thrombolytic therapy in ischemic stroke. Higashida et al. 2003: Grade 0: no perfusion Grade 1: penetration with minimal perfusion Grade 2: partial perfusion Grade 2A: only partial filling (less than two-thirds) of the entire vascular territory is visualized Grade 2B: complete filling of all of the expected vascular territory is visualized but the filling is slower than normal Grade 3: complete perfusion

Secondary Outcome Measures

Name	Time	Method
Good neurological outcome	90 days	mRS (modified Ranking Scale)= 0-2; 0 No Symptoms; 1. No significant disability, despite symptoms, able to perform all usual duties and activities; 2. Slight disability; unable to perform all previous activities but able to look after own affairs without assistance; 3. Moderate disability; requires some help, but able to walk without assistance; 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5. Severe disability bedridden incontinent and requires constant nursing care and attention; 6. Patient died

Trial Locations

Locations (11)

Schlosspark Klinik Charlottenburg; 🇩🇪 Berlin, Germany

Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Düsseldorf, Germany

Klinikum Fulda gAG; 🇩🇪 Fulda, Germany

Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Germany

Universitätsklinikum Köln; 🇩🇪 Köln, Germany

Universitätsklinikum Magdeburg A. ö. R.; 🇩🇪 Magdeburg, Germany

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

Klinikum der Universität München; 🇩🇪 München, Germany

radprax Neurozentrum Solingen; 🇩🇪 Solingen, Germany