Status:
RECRUITING
REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
Lead Sponsor:
Acandis GmbH
Conditions:
Rescue Stenting
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 25 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2027
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT05345483
Start Date
January 25 2023
End Date
January 1 2027
Last Update
December 5 2024
Active Locations (17)
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1
Institut für Radiologie und Neuroradiologie, Klinikum Aschaffenburg-Alzenau
Aschaffenburg, Germany, 63739
2
Klinik für Diagnostische Radiologie und Neuroradiologie; Universitätsklinikum Augsburg
Augsburg, Germany, 86156
3
Klinik für Diagnostische und Interventionelle Neuroradiologie; Universitätsklinikum Bonn
Bonn, Germany
4
Institut für Diagnostische und Interventionelle Radiologie, Neuroradiologie und Nuklearmedizin, Klinikum Bremerhaven-Reinkenheide
Bremerhaven, Germany