REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)

Last updated: December 4, 2024
Sponsor: Acandis GmbH
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter

Clinical Study ID

NCT05345483
RECHRUT
  • Ages > 18
  • All Genders

Study Summary

Goal of the study 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® heal Stent.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients, treated with CREDO® heal according to IFU

  • Over 18 years old

  • With acute persistent vascular occlusion due to high grade intracranial arterystenosis in the anterior or posterior circulation for which alternative therapyconcepts are not considered or fail

  • With suspected underlying stenosis of the occluded artery, which is suitable for PTAand stenting according to the treating physician's assessment and/or persistentocclusion after failed recanalization by mechanical thrombectomy of the targetregion

  • With small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion < 70 ml)

  • With symptoms onset less than 24 hours before start of the procedure

  • Treated with study device following at least one futile mechanical recanalizationattempt with a stent retriever, direct aspiration or combination of both

  • With pre-stroke disability mRS 0-2

Exclusion

Exclusion Criteria:

  • Any contraindication according to IFU and patients:

  • With atherosclerotic (probable according to clinical, anamnestic or laboratorychemical testing) vessel constrictions (high-grade intracranial stenoses > 70 %)with significant circulatory disturbance (haemodynamic infarct pattern and signs ofrestricted collaterals) and recurrent symptoms in spite of medical therapy

  • With contraindication against treatment with anti-platelet medication

  • Participating in another trial

Study Design

Total Participants: 153
Treatment Group(s): 1
Primary Treatment: Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
Phase:
Study Start date:
January 25, 2023
Estimated Completion Date:
January 31, 2027

Connect with a study center

  • Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau

    Aschaffenburg, 63739
    Germany

    Active - Recruiting

  • Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg

    Augsburg, 86156
    Germany

    Active - Recruiting

  • Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn

    Bonn,
    Germany

    Active - Recruiting

  • Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Bremerhaven-Reinkenheide

    Bremerhaven,
    Germany

    Active - Recruiting

  • Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Klinik für Radiologie und Neuroradiologie, Sana Klinikum

    Duisburg,
    Germany

    Active - Recruiting

  • Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt

    Erfurt, 99089
    Germany

    Active - Recruiting

  • Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle

    Halle (Saale), 06120
    Germany

    Active - Recruiting

  • Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinikum Altona

    Hamburg,
    Germany

    Active - Recruiting

  • Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf

    Hamburg,
    Germany

    Active - Recruiting

  • Radiologie / Neuroradiologie, Askleopis Klinik St. Georg

    Hamburg,
    Germany

    Active - Recruiting

  • Klinik für Neuroradiologie, Westpfalz-Klinikum

    Kaiserslautern,
    Germany

    Active - Recruiting

  • Abteilung für Radiologie und Nuklearmedizin, Sana Kliniken

    Lübeck,
    Germany

    Active - Recruiting

  • Interventionelle Neuroradiologie, Universitätsklinikum Münster

    Münster,
    Germany

    Active - Recruiting

  • Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg

    Oldenburg, 26122
    Germany

    Active - Recruiting

  • Klinik für Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Vest

    Recklinghausen,
    Germany

    Active - Recruiting

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

    Solingen, 42697
    Germany

    Active - Recruiting

  • Institut für Diagnostische und Interventionelle Neuroradiologie, Städtisches Klinikum

    Solingen, 42653
    Germany

    Active - Recruiting

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