AcandiS Stenting of Intracranial STENosis - regisTry (ASSISTENT)

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.

Study Overview

• Status: Recruiting
• Conditions: Intracranial Stenosis
• Intervention / Treatment: Device: Credo® Stent, NeuroSpeed® PTA balloon catheter

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Acandis GmbH; Phone Number: +49 723 1155 00; Email: info@acandis.com

Study Locations

• Germany
  • Bochum, Germany, 44892
    • Recruiting
    • Universitätsklinikum Knappschaftskrankenhaus Bochum
    • Principal Investigator: Priv. Doz. Dr. med. Sebastian Fischer
  • Düsseldorf, Germany
    • Recruiting
    • Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie
    • Contact: Bernd Turowski, Prof.
  • Essen, Germany, 45131
    • Recruiting
    • Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie
    • Contact: René Chapot, Prof.
    • Principal Investigator: Rene Chapot, Prof
  • Göttingen, Germany, 37075
    • Recruiting
    • Institut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen
    • Contact: Christian Riedel, Prof.
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf
    • Contact: Götz Thomalla, MD
    • Principal Investigator: Jan Buhk
  • Hamburg, Germany, 22769
    • Recruiting
    • Asklepios Klinik Altona, Fachbereich Neuroradiologie
    • Contact: Bernd Eckert, Prof
  • Heidelberg, Germany, 69120
    • Recruiting
    • Universitätsklinikum Heidelberg Abteilung für Neuroradiologie
    • Contact: Markus Möhlenbruch, MD
  • Homburg, Germany, 66424
    • Recruiting
    • Universitätsklinikum Homburg
    • Contact: Wolfgang Reith, Prof.
  • Ingolstadt, Germany, 85049
    • Recruiting
    • Klinikum Ingolstadt
    • Principal Investigator: Dr. Hendrik Janssen
  • Köln, Germany, 50924
    • Recruiting
    • Uniklinik Koln
    • Contact: Christoph Kabbasch, MD
  • Magdeburg, Germany, 39120
    • Recruiting
    • Otto-von-Guericke-Universität Magdeburg Universitätsklinik für Neuroradiologie
    • Contact: Daniel Behme, PD Dr.
  • Mönchengladbach, Germany, 41063
    • Recruiting
    • Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie
    • Contact: Prof. Ringelstein
  • Oldenburg, Germany, 26122
    • Recruiting
    • Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg
    • Contact: Christian Mathys, MD
  • Osnabrück, Germany, 49076
    • Recruiting
    • Klinikum Osnabrück, Klinik für Neurologie
    • Contact: Lars Krause, MD
    • Sub-Investigator: Stephan Lowens, MD
  • Recklinghausen, Germany, 45657
    • Recruiting
    • KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie
    • Contact: Christian Loehr, Dr.
  • Solingen, Germany, 42697
    • Recruiting
    • St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen
    • Contact: Hannes Nordmeyer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; a self-expanding stent is used together with a PTA balloon catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Acandis GmbH
• Investigators: Principal Investigator: Götz Thomalla, MD, Unversity Medical Center Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): April 1, 2023

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2021
• Last Update Submitted That Met QC Criteria: July 30, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: ASSISTENT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No