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

December 4, 2024 updated by: Acandis GmbH
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aschaffenburg, Germany, 63739
        • Recruiting
        • Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau
        • Contact:
      • Augsburg, Germany, 86156
        • Recruiting
        • Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg
        • Contact:
      • Bonn, Germany
        • Recruiting
        • Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn
        • Contact:
      • Bremerhaven, Germany
        • Recruiting
        • Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Bremerhaven-Reinkenheide
        • Contact:
      • Dresden, Germany, 01307
        • Recruiting
        • Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Dresden
        • Contact:
      • Duisburg, Germany
        • Recruiting
        • Klinik für Radiologie und Neuroradiologie, Sana Klinikum
        • Contact:
      • Erfurt, Germany, 99089
        • Recruiting
        • Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt
        • Contact:
      • Halle (Saale), Germany, 06120
        • Recruiting
        • Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle
        • Contact:
      • Hamburg, Germany
        • Recruiting
        • Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinikum Altona
        • Contact:
      • Hamburg, Germany
        • Recruiting
        • Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
        • Contact:
      • Hamburg, Germany
        • Recruiting
        • Radiologie / Neuroradiologie, Askleopis Klinik St. Georg
        • Contact:
      • Kaiserslautern, Germany
        • Recruiting
        • Klinik für Neuroradiologie, Westpfalz-Klinikum
        • Contact:
      • Lübeck, Germany
        • Recruiting
        • Abteilung für Radiologie und Nuklearmedizin, Sana Kliniken
        • Contact:
      • Münster, Germany
        • Recruiting
        • Interventionelle Neuroradiologie, Universitätsklinikum Münster
        • Contact:
      • Oldenburg, Germany, 26122
        • Recruiting
        • Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg
        • Contact:
      • Recklinghausen, Germany
        • Recruiting
        • Klinik für Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Vest
        • Contact:
      • Solingen, Germany, 42653
        • Recruiting
        • Institut für Diagnostische und Interventionelle Neuroradiologie, Städtisches Klinikum
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients who were treated with CREDO® heal due to acute ischemic stroke and proven occlusion with unsuccessful recanalization after endovascular treatment with mechanical thrombectomy and suspected underlying stenosis of the occluded intracranial artery, which is suitable to PTA and stenting based on the decision of the treating physician.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at the end of the treatment procedure.
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).
90 (± 20) days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acandis GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 19, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Estimated)

December 5, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • RECHRUT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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