Clinical trial NCT05345483: REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
Official title: REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rescue Stenting
Lead sponsor: Acandis GmbH
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure.
timeFrame: Assessed at the end of the treatment procedure.
measure: Primary Clinical Efficacy Endpoint- proportion of patients with mRS 0-2 at 90 (± 20) days after procedure.
timeFrame: 90 (± 20) days.
Secondary outcomes:
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau
city: Augsburg
country: Germany
facility: Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg
city: Bonn
country: Germany
facility: Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn
city: Bremerhaven
country: Germany
facility: Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Bremerhaven-Reinkenheide
city: Dresden
country: Germany
facility: Institut und Poliklinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum Dresden
city: Duisburg
country: Germany
facility: Klinik für Radiologie und Neuroradiologie, Sana Klinikum
city: Erfurt
country: Germany
facility: Diagnostische und interventionelle Radiologie, Helios Klinikum Erfurt
city: Halle (Saale)
country: Germany
facility: Diagnostische und Interventionelle Neuroradiologie, Universitätsmedizin Halle
city: Hamburg
country: Germany
facility: Abteilung für Radiologie, Neuroradiologie und Nuklearmedizin, Asklepios Klinikum Altona
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Neuroradiologische Diagnostik und Intervention, Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Radiologie / Neuroradiologie, Askleopis Klinik St. Georg
city: Kaiserslautern
country: Germany
facility: Klinik für Neuroradiologie, Westpfalz-Klinikum
city: Lübeck
country: Germany
facility: Abteilung für Radiologie und Nuklearmedizin, Sana Kliniken
city: Münster
country: Germany
facility: Interventionelle Neuroradiologie, Universitätsklinikum Münster
city: Oldenburg
country: Germany
facility: Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg
city: Recklinghausen
country: Germany
facility: Klinik für Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Vest
city: Solingen
country: Germany
facility: Institut für Diagnostische und Interventionelle Neuroradiologie, Städtisches Klinikum
Study officials:
References: