Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)

Study Overview
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Brief Summary
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Study objective 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® stent together with the NeuroSpeed® PTA balloon catheter.

Detailed Description
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Prospective, interventional treatment, single-arm, open-label, multi-center trial.

Official Title
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Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)

Conditions
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Acute Ischemic Stroke, Intracranial Stenosis

Intervention / Treatment
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* Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute ischemic stroke from large vessel occlusion (LVO) Failed recanalization after treatment with thrombectomy, i.e. persistent occlusion of intracranial internal carotid artery (ICA), proximal segment (M1, M2) of the middle cerebral artery (MCA) (TICI 0-1) Small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10, DWI lesion < 70 ml) Suspected underlying stenosis of the occluded artery amenable to stenting by judgement of the treating neurointerventionalist Age 18- 80 years Informed consent (see below) Decision to perform angioplasty and stenting < 12 hours of symptom onset Previous passage of occlusion with microcatheter obtained Exclusion Criteria: Large infarct core prior to initiation of thrombectomy (CT ASPECTS 0-5, DWI lesion > 70 ml) Vessel occlusion or stenosis of different known or suspected cause than atherosclerosis (e.g. vasculitis) Pre-stroke disability (MRS > 2) Any sign of intracranial haemorrhage on brain imaging prior to thrombectomy Any sign of intracranial vessel perforation during thrombectomy Contraindication against treatment with double anti-platelet treatment Current effective use of oral anticoagulants (e.g. INR > 1.7 for Vitamin K antagonists) More than 3 attempts for recanalization of target lesion prior to the use of the study device. Stenosis longer than the working length of the NeuroSpeed PTA balloon catheter. Diameter of the healthy vessel proximal and distal to the stenosis prevents save treatment with the NeuroSpeed PTA balloon catheter or is outside the indicated range of the Credo stent. Diameter of the target area is outside the indicated range of the Credo stent after predilation. Contraindication against anti-platelet or anticoagulation therapy Heavily calcified lesions that may prevent access or safe stent placement. Pregnant and breastfeeding women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, interventional treatment, single-arm, open-label, multi-centre trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ACUTE<br>Patients with acute ischemic stroke and proven large vessel occlusion (e.g. intracranial internal carotid artery or middle cerebral artery) with unsuccessful recanalization after endovascular treatment with mechanical thrombectomy and suspected underlying stenosis of the occluded intracranial artery amenable to stenting based on judgment by the treating neurointerventionalist. | Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.<br>* Self-expandable Credo® stent together with NeuroSpeed® PTA balloon catheter. Credo® and NeuroSpeed® are already CE approved products, for which within ACUTE an additional new indication shall be examined.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-Primary Technical Efficacy Endpoint | Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting). | Assessed after interventional procedure | 
| Co-Primary Clinical Efficacy Endpoint | Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2). | 90 +/- 10 days after stroke | 
| Primary Safety Endpoints | Symptomatic intracranial hemorrhage (SICH) as defined in SITS-MOST (within 18-36 hours of treatment) Device-related procedural complications: Dissection, perforation or rupture of the target vessel, embolism, stent thrombosis or occlusion, stent migration. | Within 18-36 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Efficacy Endpoints | Categorical shift in MRS 90 (±10) days after stroke Functional health status and quality of life 90 (±10) days after stroke (EQ-5D) Infarct growth by 18-36 hours after stroke as compared to predicted infarct growth Frequency of residual stenosis > 50 % | 90 +/- 10 days after stroke | 
| Secondary Safety Endpoints | Ischemic stroke in downstream territory of the occluded vessel within 90 (±10) days after stroke Parenchymal hemorrhage type 2 (PH-2) after 18-36 hours Embolization in new territories Mortality 90 (±10) days after stroke Death or dependency 90 (±10) days after stroke (MRS 4-6) | 90 +/- 10 days after stroke |