REscue Stenting With CREDO® Heal for Recanalisation After Unsuccessful Thrombectomy (RECHRUT)

Acandis

Status: Enrolling

Conditions: Rescue Stenting

Treatments: Device: Rescue stenting with CREDO heal Stent together with NeuroSpeed PTA Balloon Catheter

Study type: Observational

Funder types: Industry

Identifiers

NCT05345483

RECHRUT

Details and patient eligibility

About

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.

Enrollment: 153 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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