Rescue Stenting
Conditions
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.
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
Sponsors
Acandis GmbH
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Technical Efficacy Endpoint- proportion of patients with eTICI 2b-3 at the end of the treatment procedure. | Assessed at the end of the treatment procedure. | • Technical success defined as successful recanalization of the occluded vessel (expanded treatment in cerebral ischemia score (eTICI) of 2b-3) at the end of the procedure. |
| Primary Clinical Efficacy Endpoint- proportion of patients with mRS 0-2 at 90 (± 20) days after procedure. | 90 (± 20) days. | • Good clinical outcome 90 (± 20) days after stroke defined as a score of 0-2 on the modified Ranking Scale (mRS 0-2). |
Countries
Germany
Outcome results
None listed