RecruitingNCT05345483
REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)
Sponsor
Acandis GmbH
Enrollment
153 participants
Start Date
Jan 25, 2023
Study Type
OBSERVATIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria8
- 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 Criteria4
- 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
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Interventions
DEVICERescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT05345483