Intracranial Stenosis
Conditions
Brief summary
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
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.
Interventions
DEVICECredo® Stent, NeuroSpeed® PTA balloon catheter
a self-expanding stent is used together with a PTA balloon catheter
Sponsors
Acandis GmbH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU)
Exclusion criteria
* There are no specific
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients with Cerebrovascular Events | 30 days after the interventional procedure | * 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 |
| Rate of Technical Success | During interventional procedure | • Technical Success |
| Number of Patients with Periprocedural Vascular Events | Periprocedural, until 30 days after the interventional procedure | * 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 |
| Number of Patients with Cerebrovascular events | At hospital discharge - befor the patient leaves the hospital after the intervention; up to 2 weeks, whichever came first | * 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 |
Secondary
| Measure | 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 |
Countries
Germany
Contacts
Primary ContactAcandis GmbH
Outcome results
None listed