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

Recruiting

• Conditions: Rescue Stenting

• Registration Number: NCT05345483
• Lead Sponsor: Acandis GmbH

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-07
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-26
• Study Start: 2023-01-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-05
• Primary Completion: 2026-09
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 153

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure.	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.
Primary Clinical Efficacy Endpoint- proportion of patients with mRS 0-2 at 90 (± 20) days after procedure.	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).

Trial Locations

Locations (17)

Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau; 🇩🇪 Aschaffenburg, Germany

Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany

Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt; 🇩🇪 Erfurt, Germany

Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle; 🇩🇪 Halle (Saale), Germany

Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg; 🇩🇪 Oldenburg, Germany

Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg; 🇩🇪 Augsburg, Germany

Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn; 🇩🇪 Bonn, Germany

Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Bremerhaven-Reinkenheide; 🇩🇪 Bremerhaven, Germany

Klinik für Radiologie und Neuroradiologie, Sana Klinikum; 🇩🇪 Duisburg, Germany

Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinikum Altona; 🇩🇪 Hamburg, Germany

Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Radiologie / Neuroradiologie, Askleopis Klinik St. Georg; 🇩🇪 Hamburg, Germany

Klinik für Neuroradiologie, Westpfalz-Klinikum; 🇩🇪 Kaiserslautern, Germany

Abteilung für Radiologie und Nuklearmedizin, Sana Kliniken; 🇩🇪 Lübeck, Germany

Interventionelle Neuroradiologie, Universitätsklinikum Münster; 🇩🇪 Münster, Germany

Klinik für Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Vest; 🇩🇪 Recklinghausen, Germany

Institut für Diagnostische und Interventionelle Neuroradiologie, Städtisches Klinikum; 🇩🇪 Solingen, Germany