AcandiS Stenting of Intracranial STENosis - regisTry

NCT03902444 | Unknown DMC

• 1 other identifier: ASSISTENT
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 16

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.

Conditions

Intracranial Stenosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (1)

Credo® Stent and NeuroSpeed® PTA balloon catheter

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

Device: Credo® Stent, NeuroSpeed® PTA balloon catheter

Interventions

Credo® Stent, NeuroSpeed® PTA balloon catheter DEVICE

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

Credo® Stent and NeuroSpeed® PTA balloon catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Acandis GmbH: lead

Study Sites (16)

Universitätsklinikum Knappschaftskrankenhaus Bochum

Bochum, 44892, Germany

RECRUITING

Uniklinik Köln

Cologne, 50924, Germany

RECRUITING

Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie

Düsseldorf, Germany

RECRUITING

Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie

Essen, 45131, Germany

RECRUITING

Institut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen

Göttingen, 37075, Germany

RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Asklepios Klinik Altona, Fachbereich Neuroradiologie

Hamburg, 22769, Germany

RECRUITING

Universitätsklinikum Heidelberg Abteilung für Neuroradiologie

Heidelberg, 69120, Germany

RECRUITING

Universitätsklinikum Homburg

Homburg, 66424, Germany

RECRUITING

Klinikum Ingolstadt

Ingolstadt, 85049, Germany

RECRUITING

Otto-von-Guericke-Universität Magdeburg Universitätsklinik für Neuroradiologie

Magdeburg, 39120, Germany

RECRUITING

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

Mönchengladbach, 41063, Germany

RECRUITING

Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg

Oldenburg, 26122, Germany

RECRUITING

Klinikum Osnabrück, Klinik für Neurologie

Osnabrück, 49076, Germany

RECRUITING

KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie

Recklinghausen, 45657, Germany

RECRUITING

St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen

Solingen, 42697, Germany

RECRUITING

Study Officials

• Götz Thomalla, MD

  Unversity Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Acandis GmbH

CONTACT

+49 723 1155 00; info@acandis.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: April 4, 2019
• Study Start: May 1, 2016
• Primary Completion: March 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 1, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (16)