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

NCT05345483 | Recruiting

• 1 other identifier: RECHRUT
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 17

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.

Conditions

Rescue Stenting

Outcome Measures

Primary Outcomes (2)

• Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 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.

  • 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.

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acandis GmbH: lead

Study Sites (17)

Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau

Aschaffenburg, 63739, Germany

RECRUITING

Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg

Augsburg, 86156, 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, 01307, Germany

RECRUITING

Klinik für Radiologie und Neuroradiologie, Sana Klinikum

Duisburg, Germany

RECRUITING

Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt

Erfurt, 99089, Germany

RECRUITING

Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle

Halle, 06120, 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, 26122, Germany

RECRUITING

Klinik für Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Vest

Recklinghausen, Germany

RECRUITING

Institut für Diagnostische und Interventionelle Neuroradiologie, Städtisches Klinikum

Solingen, 42653, Germany

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 26, 2022
• Study Start: January 25, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (17)