Skip to main content
OpenTrials
Completed

NCT Number: NCT04479020

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schlosspark Klinik Charlottenburg, Berlin, Germany

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mechanical Thrombectomy

Device

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)

Primary outcomes

  1. Primary efficacy endpoint

    Time frame: 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

  2. Primary safety endpoint

    Time frame: 48 hours

    • Symptomatic intracranial hemorrhage (sICH): ICH in periprocedural (<48 hours) CT associated with worsening of NIHSS by ≥ 4 points within 48 hours.

  3. Primary safety endpoint

    Time frame: 90 days

    Rates of device and procedure related (serious) adverse events ((S)AEs)

  4. Primary Safety endpoint

    Time frame: 90 days

    Mortality

Secondary outcomes

  1. Good neurological outcome

    Time frame: 90 days

    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

Sponsors and collaborators

Lead sponsor

Acandis GmbH

Industry

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 21, 2020
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.