Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)

Last updated: October 14, 2021
Sponsor: Acandis GmbH
Overall Status: Terminated

Phase

N/A

Condition

Thrombosis

Stroke

Blood Clots

Treatment

N/A

Clinical Study ID

NCT03955835
ACUTE
  • Ages 18-80
  • All Genders

Study Summary

Study objective is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable Credo® stent together with the NeuroSpeed® PTA balloon catheter.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Acute ischemic stroke from large vessel occlusion (LVO)
  • Failed recanalization after treatment with thrombectomy, i.e. persistent occlusion ofintracranial internal carotid artery (ICA), proximal segment (M1, M2) of the middlecerebral artery (MCA) (TICI 0-1)
  • Small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10,DWI lesion < 70 ml)
  • Suspected underlying stenosis of the occluded artery amenable to stenting by judgementof the treating neurointerventionalist
  • Age 18- 80 years
  • Informed consent (see below)
  • Decision to perform angioplasty and stenting < 12 hours of symptom onset
  • Previous passage of occlusion with microcatheter obtained

Exclusion

Exclusion Criteria:

  • Large infarct core prior to initiation of thrombectomy (CT ASPECTS 0-5, DWI lesion > 70 ml)
  • Vessel occlusion or stenosis of different known or suspected cause thanatherosclerosis (e.g. vasculitis)
  • Pre-stroke disability (MRS > 2)
  • Any sign of intracranial haemorrhage on brain imaging prior to thrombectomy
  • Any sign of intracranial vessel perforation during thrombectomy
  • Contraindication against treatment with double anti-platelet treatment
  • Current effective use of oral anticoagulants (e.g. INR > 1.7 for Vitamin Kantagonists)
  • More than 3 attempts for recanalization of target lesion prior to the use of the studydevice.
  • Stenosis longer than the working length of the NeuroSpeed PTA balloon catheter.
  • Diameter of the healthy vessel proximal and distal to the stenosis prevents savetreatment with the NeuroSpeed PTA balloon catheter or is outside the indicated rangeof the Credo stent.
  • Diameter of the target area is outside the indicated range of the Credo stent afterpredilation.
  • Contraindication against anti-platelet or anticoagulation therapy
  • Heavily calcified lesions that may prevent access or safe stent placement.
  • Pregnant and breastfeeding women

Study Design

Total Participants: 27
Study Start date:
August 09, 2019
Estimated Completion Date:
September 22, 2021

Study Description

Prospective, interventional treatment, single-arm, open-label, multi-center trial.

Connect with a study center

  • Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie

    Hamburg, 22763
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg

    Heidelberg,
    Germany

    Site Not Available

  • Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes

    Homburg, 66424
    Germany

    Site Not Available

  • Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie

    Mönchengladbach, 41063
    Germany

    Site Not Available

  • Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg

    Oldenburg, 26122
    Germany

    Site Not Available

  • Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik

    Osnabrück, 49028
    Germany

    Site Not Available

  • Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik

    Solingen, 42697
    Germany

    Site Not Available

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