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

NCT ID: NCT05345483

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-25

Study Completion Date

2027-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rescue Stenting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Acandis GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau

Aschaffenburg, , Germany

Site Status RECRUITING

Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg

Augsburg, , Germany

Site Status RECRUITING

Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn

Bonn, , Germany

Site Status RECRUITING

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

Bremerhaven, , Germany

Site Status RECRUITING

Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Dresden

Dresden, , Germany

Site Status RECRUITING

Klinik für Radiologie und Neuroradiologie, Sana Klinikum

Duisburg, , Germany

Site Status RECRUITING

Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt

Erfurt, , Germany

Site Status RECRUITING

Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle

Halle, , Germany

Site Status RECRUITING

Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinikum Altona

Hamburg, , Germany

Site Status RECRUITING

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

Hamburg, , Germany

Site Status RECRUITING

Radiologie / Neuroradiologie, Askleopis Klinik St. Georg

Hamburg, , Germany

Site Status RECRUITING

Klinik für Neuroradiologie, Westpfalz-Klinikum

Kaiserslautern, , Germany

Site Status RECRUITING

Abteilung für Radiologie und Nuklearmedizin, Sana Kliniken

Lübeck, , Germany

Site Status RECRUITING

Interventionelle Neuroradiologie, Universitätsklinikum Münster

Münster, , Germany

Site Status RECRUITING

Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg

Oldenburg, , Germany

Site Status RECRUITING

Klinik für Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Vest

Recklinghausen, , Germany

Site Status RECRUITING

Institut für Diagnostische und Interventionelle Neuroradiologie, Städtisches Klinikum

Solingen, , Germany

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Germany

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

PD Dr. med. Volker Maus

Role: primary

Prof. Dr. med. Ansgar Berlis

Role: primary

Prof. Dr. med. Franziska Dorn

Role: primary

Dr. med. Timo Phung

Role: primary

Dr. med. Johannes Gerber

Role: primary

Dr. med. Martin Schlunz-Hendann

Role: primary

PD Dr. med. Donald Lobsien

Role: primary

PD Dr. med. Stefan Schob

Role: primary

Prof. Dr. med. Bernd Eckert

Role: primary

Dr. med. Maxim Bester

Role: primary

Dr. med. Jan-Hendrik Buhk

Role: primary

Dr. med. Andreas Simgen

Role: primary

Dr. med. Christian Dyzmann

Role: primary

Dr. med. Christian-Paul Stracke

Role: primary

PD Dr. med. Christian Mathys

Role: primary

Dr. med. Christian Loehr

Role: primary

Dr. med. Hannes Nordmeyer, PI

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RECHRUT

Identifier Type: -

Identifier Source: org_study_id