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Clinical Trials in Germany / NCT05345483
Recruiting Observational

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

NCT05345483 · tracked via the Priya Life Science Germany tracker
Phase
Observational
Started
2023-01-25
Last updated
2024-12-05

Condition(s) studied

Rescue Stenting

Investigational drug(s) / intervention(s)

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

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

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (17)

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

More Acandis GmbH trials in Germany

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05345483 on ClinicalTrials.gov ↗ ← All trials in Germany