REcanalization of Distal Cerebral Vessels in Acute Stroke Using ApeRio®

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.

Study Overview

• Status: Completed
• Conditions: Acute Stroke
• Intervention / Treatment: Device: Mechanical Thrombectomy

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 Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany
    • Schlosspark Klinik Charlottenburg
  • Bonn, Germany, 53127
    • Universitätsklinikum Bonn
  • Düsseldorf, Germany
    • Universitätsklinikum Düsseldorf
  • Fulda, Germany
    • Klinikum Fulda gAG
  • Göttingen, Germany
    • Universitätsmedizin Göttingen
  • Homburg, Germany
    • Universitatsklinikum des Saarlandes
  • Köln, Germany
    • Universitätsklinikum Köln
  • Magdeburg, Germany
    • Universitätsklinikum Magdeburg A. ö. R.
  • Minden, Germany
    • Johannes Wesling Klinikum Minden
  • München, Germany, 80336
    • Klinikum der Universität München
  • Solingen, Germany, 42697
    • radprax Neurozentrum Solingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients treated with an APERIO® or APERIO® Hybrid(17) Thrombectomy Device due to a thrombotic occlusion in distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA).

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary efficacy endpoint	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	Immediatley after interventional procedure
Primary safety endpoint	• Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (<48 hours) CT associated with worsening of NIHSS by ≥ 4 points within 48 hours.	48 hours
Primary safety endpoint	Rates of device and procedure related (serious) adverse events ((S)AEs)	90 days
Primary Safety endpoint	Mortality	90 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Acandis GmbH

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): January 30, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (Actual): July 21, 2020

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: REVISAR Revision 4.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No