AcandiS Stenting of Intracranial STENosis - regisTry

Study Overview
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Brief Summary
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ASSISTENT is designed to collect comprehensive information on technical and clinical safety of the use of Credo® stent together with the NeuroSpeed® PTA balloon catheter in clinical practice in an open registry.

Detailed Description
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ASSISTENT is subdivided into two components. The first part only requires recording of data acquired in routine clinical practice during the treatment of patients with intracranial stenosis with the self-expandable Credo® stent until discharge. This comprises demographic data, data concerning the qualifying clinical event, limited data on medical history and medication, information about the intervention including technical success and periprocedural complications or events, and information about events and clinical status during the in-hospital treatment until hospital discharge. The second part of the registry consists of a follow-up visit 30 days after the interventional procedure which will be conducted outside of clinical practice.

Official Title
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AcandiS Stenting of Intracranial STENosis - regisTry

Conditions
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Intracranial Stenosis

Intervention / Treatment
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* Device: Credo® Stent, NeuroSpeed® PTA balloon catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU) Exclusion Criteria: There are no specific exclusion criteria (see product IFU)

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Credo® Stent and NeuroSpeed® PTA balloon catheter<br>Patients treated with Credo® Stent and NeuroSpeed® PTA balloon catheter in the clinical routine | Device: Credo® Stent, NeuroSpeed® PTA balloon catheter<br>* a self-expanding stent is used together with a PTA balloon catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Technical Success | • Technical Success | During interventional procedure | 
| Number of Patients with Periprocedural Vascular Events | Intracranial haemorrhage (symptomatic / asymptomatic) Death TIA in the region of the target vessel Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel Disabling ischemic stroke (MRS 3-6) in the region of the target vessel TIA outside the region of the target vessel Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel | Periprocedural, until 30 days after the interventional procedure | 
| Number of Patients with Cerebrovascular events | Intracranial haemorrhage (symptomatic / asymptomatic) Death TIA in the region of the target vessel Non-disabling ischemic stroke (MRS 0-2) in the region of the target vessel Disabling ischemic stroke (MRS 3-6) in the region of the target vessel TIA outside the region of the target vessel Non-disabling ischemic stroke (MRS 0-2) outside the region of the target vessel Disabling ischemic stroke (MRS 3-6) outside the region of the target vessel | At hospital discharge - befor the patient leaves the hospital after the intervention; up to 2 weeks, whichever came first | 
| Number of Patients with Cerebrovascular Events | Intracranial haemorrhage (symptomatic / asymptomatic) Death TIA Non-disabling ischemic stroke (MRS 0-2) Disabling ischemic stroke (MRS 3-6) Interventional re-treatment of the target vessel | 30 days after the interventional procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients with Dissection of the target vessel |  | During interventional procedure | 
| Number of Patients with Occlusion of the target vessel |  | 30 days after the interventional procedure | 
| Number of Patients with Myocardial infarction |  | 30 days after the interventional procedure | 
| Number of Patients with Severe extracranial hemorrhage (requiring surgical treatment or transfusion) |  | 30 days after the interventional procedure |