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NCT Number: NCT05345483

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

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.

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Key information

Conditions

Rescue Stenting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau, Aschaffenburg, Germany

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Who can participate

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

Inclusion criteria

  • Patients, treated with CREDO® heal according to IFU
  • Over 18 years old
  • With acute persistent vascular occlusion due to high grade intracranial artery stenosis in the anterior or posterior circulation for which alternative therapy concepts are not considered or fail
  • With suspected underlying stenosis of the occluded artery, which is suitable for PTA and stenting according to the treating physician's assessment and/or persistent occlusion after failed recanalization by mechanical thrombectomy of the target region
  • 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 recanalization attempt with a stent retriever, direct aspiration or combination of both
  • With pre-stroke disability mRS 0-2

Exclusion criteria

  • Any contraindication according to IFU and patients:
  • With atherosclerotic (probable according to clinical, anamnestic or laboratory chemical testing) vessel constrictions (high-grade intracranial stenoses > 70 %) with significant circulatory disturbance (haemodynamic infarct pattern and signs of restricted collaterals) and recurrent symptoms in spite of medical therapy
  • With contraindication against treatment with anti-platelet medication
  • Participating in another trial

Treatment and study plan

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

Device

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

Primary outcomes

  1. Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure.

    Time frame: Assessed at the end of the treatment procedure.

    • Technical success defined as successful recanalization of the occluded vessel (expanded treatment in cerebral ischemia score (eTICI) of 2b-3) at the end of the procedure.

  2. Primary Clinical Efficacy Endpoint- proportion of patients with mRS 0-2 at 90 (± 20) days after procedure.

    Time frame: 90 (± 20) days.

    • Good clinical outcome 90 (± 20) days after stroke defined as a score of 0-2 on the modified Ranking Scale (mRS 0-2).

Sponsors and collaborators

Lead sponsor

Acandis GmbH

Industry

Registry information

Acronym: RECHRUT

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Apr 26, 2022
Registry last updated
Dec 5, 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.

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