AcandiS Stenting of Intracranial STENosis - regisTry

Recruiting

• Conditions: Intracranial Stenosis
• Interventions: Device: Credo® Stent, NeuroSpeed® PTA balloon catheter

• Registration Number: NCT03902444
• Lead Sponsor: Acandis GmbH

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.

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2019-03-27
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-04
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-01
• Primary Completion: 2025-03
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Credo® Stent and NeuroSpeed® PTA balloon catheter	Credo® Stent, NeuroSpeed® PTA balloon catheter	Patients treated with Credo® Stent and NeuroSpeed® PTA balloon catheter in the clinical routine

Primary Outcome Measures

Name	Time	Method
Rate of Technical Success	During interventional procedure	• Technical Success
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
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	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

Secondary Outcome Measures

Name	Time	Method
Number of Patients with Occlusion of the target vessel	30 days after the interventional procedure
Number of Patients with Dissection of the target vessel	During 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

Trial Locations

Locations (16)

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitätsklinikum Heidelberg Abteilung für Neuroradiologie; 🇩🇪 Heidelberg, Germany

Universitätsklinikum Homburg; 🇩🇪 Homburg, Germany

Otto-von-Guericke-Universität Magdeburg Universitätsklinik für Neuroradiologie; 🇩🇪 Magdeburg, Germany

KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie; 🇩🇪 Recklinghausen, Germany

Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie; 🇩🇪 Essen, Germany

Klinikum Ingolstadt; 🇩🇪 Ingolstadt, Germany

Uniklinik Köln; 🇩🇪 Köln, Germany

Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie; 🇩🇪 Mönchengladbach, Germany

Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg; 🇩🇪 Oldenburg, Germany

Klinikum Osnabrück, Klinik für Neurologie; 🇩🇪 Osnabrück, Germany

Institut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen; 🇩🇪 Göttingen, Germany

Universitätsklinikum Knappschaftskrankenhaus Bochum; 🇩🇪 Bochum, Germany

Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie; 🇩🇪 Düsseldorf, Germany

Asklepios Klinik Altona, Fachbereich Neuroradiologie; 🇩🇪 Hamburg, Germany

St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen; 🇩🇪 Solingen, Germany