Recruiting NCT05345483
REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter.
- Who it may be relevant to
- Registry conditions: Rescue Stenting. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
Primary outcome measures
- Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure. [Time frame: 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. [Time frame: 90 (± 20) days.]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Germany · 17 centers
- Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau — Aschaffenburg
- Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg — Augsburg
- Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn — Bonn
- Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmed — Bremerhaven
- Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitä — Dresden
- Klinik für Radiologie und Neuroradiologie, Sana Klinikum — Duisburg
- Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt — Erfurt
- Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle — Halle
- … and 9 more centers
Identifiers
NCT: NCT05345483 · RECHRUT