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AcandiS Stenting of Intracranial STENosis - regisTry

NCT ID: NCT03902444

Last Updated: 2023-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-31

Study Completion Date

2025-10-31

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.

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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.

Conditions

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Intracranial Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Credo® Stent and NeuroSpeed® PTA balloon catheter

Patients treated with Credo® Stent and NeuroSpeed® PTA balloon catheter in the clinical routine

Credo® Stent, NeuroSpeed® PTA balloon catheter

Intervention Type DEVICE

a self-expanding stent is used together with a PTA balloon catheter

Interventions

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Credo® Stent, NeuroSpeed® PTA balloon catheter

a self-expanding stent is used together with a PTA balloon catheter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\- Treatment with Credo® for symptomatic atherosclerotic intracranial artery stenosis (see product IFU)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Acandis GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Götz Thomalla, MD

Role: PRINCIPAL_INVESTIGATOR

Unversity Medical Center Hamburg-Eppendorf

Locations

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Universitätsklinikum Knappschaftskrankenhaus Bochum

Bochum, , Germany

Site Status RECRUITING

Uniklinik Köln

Cologne, , Germany

Site Status RECRUITING

Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie

Düsseldorf, , Germany

Site Status RECRUITING

Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie

Essen, , Germany

Site Status RECRUITING

Institut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen

Göttingen, , Germany

Site Status RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Asklepios Klinik Altona, Fachbereich Neuroradiologie

Hamburg, , Germany

Site Status RECRUITING

Universitätsklinikum Heidelberg Abteilung für Neuroradiologie

Heidelberg, , Germany

Site Status RECRUITING

Universitätsklinikum Homburg

Homburg, , Germany

Site Status RECRUITING

Klinikum Ingolstadt

Ingolstadt, , Germany

Site Status RECRUITING

Otto-von-Guericke-Universität Magdeburg Universitätsklinik für Neuroradiologie

Magdeburg, , Germany

Site Status RECRUITING

Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie

Mönchengladbach, , Germany

Site Status RECRUITING

Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg

Oldenburg, , Germany

Site Status RECRUITING

Klinikum Osnabrück, Klinik für Neurologie

Osnabrück, , Germany

Site Status RECRUITING

KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie

Recklinghausen, , Germany

Site Status RECRUITING

St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen

Solingen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Acandis GmbH

Role: CONTACT

[email protected]
+49 723 1155 00

Facility Contacts

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Christoph Kabbasch, MD

Role: primary

Bernd Turowski, Prof.

Role: primary

Rene Chapot, Prof.

Role: primary

Christian Riedel, Prof.

Role: primary

Götz Thomalla, MD

Role: primary

Bernd Eckert, Prof

Role: primary

Markus Möhlenbruch, MD

Role: primary

Wolfgang Reith, Prof.

Role: primary

Daniel Behme, PD Dr.

Role: primary

Prof. Ringelstein

Role: primary

Christian Mathys, MD

Role: primary

Lars Krause, MD

Role: primary

Christian Loehr, Dr.

Role: primary

Hannes Nordmeyer, MD

Role: primary

Other Identifiers

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ASSISTENT

Identifier Type: -

Identifier Source: org_study_id

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