Evaluating stenting for patients with unsuccessful thrombectomy in stroke treatment
REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
Acandis GmbH · NCT05345483
This study is testing if a new stent can help stroke patients who didn't get better after a previous treatment to open blocked blood vessels in their brain.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 153 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Acandis GmbH (industry) |
| Locations | 17 sites (Aschaffenburg and 16 other locations) |
| Trial ID | NCT05345483 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy and safety of using the CREDO® Heal Stent for acute permanent stenting in patients who have experienced unsuccessful recanalization by thrombectomy due to symptomatic intracranial stenosis. It focuses on individuals with acute ischemic stroke caused by large vessel occlusion, where alternative therapies have failed or are not viable. The intervention involves the use of the CREDO® Heal Stent in conjunction with a NeuroSpeed PTA Balloon Catheter following at least one failed mechanical recanalization attempt. The study will evaluate outcomes related to the procedure's effectiveness and safety in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with acute persistent vascular occlusion due to high-grade intracranial artery stenosis and a small to moderate infarct core.
Not a fit: Patients with contraindications to the CREDO® Heal Stent or those who do not meet the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with acute ischemic stroke who do not respond to standard thrombectomy procedures.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for patients with acute ischemic stroke, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Aschaffenburg and 16 other locations
- 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)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rescue Stenting