Clinical trial NCT03902444: AcandiS Stenting of Intracranial STENosis - regisTry
Official title: AcandiS Stenting of Intracranial STENosis - regisTry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intracranial Stenosis
Lead sponsor: Acandis GmbH
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 18 with symptomatic intracranial artery stenosis treated with the self-expandable Credo® stent in the participating sites in clinical practice.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of Technical Success
timeFrame: During interventional procedure
measure: Number of Patients with Periprocedural Vascular Events
timeFrame: Periprocedural, until 30 days after the interventional procedure
measure: Number of Patients with Cerebrovascular events
timeFrame: At hospital discharge - befor the patient leaves the hospital after the intervention; up to 2 weeks, whichever came first
measure: Number of Patients with Cerebrovascular Events
timeFrame: 30 days after the interventional procedure
Secondary outcomes:
measure: Number of Patients with Dissection of the target vessel
timeFrame: During interventional procedure
measure: Number of Patients with Occlusion of the target vessel
timeFrame: 30 days after the interventional procedure
measure: Number of Patients with Myocardial infarction
timeFrame: 30 days after the interventional procedure
measure: Number of Patients with Severe extracranial hemorrhage (requiring surgical treatment or transfusion)
timeFrame: 30 days after the interventional procedure
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Universitätsklinikum Knappschaftskrankenhaus Bochum
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie
city: Essen
country: Germany
facility: Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie
city: Göttingen
country: Germany
facility: Institut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona, Fachbereich Neuroradiologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg Abteilung für Neuroradiologie
city: Homburg
country: Germany
facility: Universitätsklinikum Homburg
city: Ingolstadt
country: Germany
facility: Klinikum Ingolstadt
city: Köln
country: Germany
facility: Uniklinik Köln
city: Magdeburg
country: Germany
facility: Otto-von-Guericke-Universität Magdeburg Universitätsklinik für Neuroradiologie
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie
city: Oldenburg
country: Germany
facility: Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück, Klinik für Neurologie
city: Recklinghausen
country: Germany
facility: KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie
city: Solingen
country: Germany
facility: St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen
Study officials:
affiliation: Unversity Medical Center Hamburg-Eppendorf
name: Götz Thomalla, MD
role: PRINCIPAL_INVESTIGATOR
References: