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Trial record 1 of 1 for:    NCT03902444
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AcandiS Stenting of Intracranial STENosis - regisTry (ASSISTENT)

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ClinicalTrials.gov Identifier: NCT03902444
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Intracranial Stenosis 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.

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AcandiS Stenting of Intracranial STENosis - regisTry
Actual Study Start Date : May 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

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




Primary Outcome Measures :
  1. Rate of Technical Success [ Time Frame: During interventional procedure ]
    • Technical Success

  2. Number of Patients with Periprocedural Vascular Events [ Time Frame: 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

  3. Number of Patients with Cerebrovascular events [ Time Frame: 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

  4. Number of Patients with Cerebrovascular Events [ Time Frame: 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 :
  1. Number of Patients with Dissection of the target vessel [ Time Frame: During interventional procedure ]
  2. Number of Patients with Occlusion of the target vessel [ Time Frame: 30 days after the interventional procedure ]
  3. Number of Patients with Myocardial infarction [ Time Frame: 30 days after the interventional procedure ]
  4. Number of Patients with Severe extracranial hemorrhage (requiring surgical treatment or transfusion) [ Time Frame: 30 days after the interventional procedure ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902444


Contacts
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Contact: Acandis GmbH +49 723 1155 00 info@acandis.com

Locations
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Germany
Universitätsklinikum Knappschaftskrankenhaus Bochum Recruiting
Bochum, Germany, 44892
Principal Investigator: Priv. Doz. Dr. med. Sebastian Fischer         
Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie Recruiting
Essen, Germany, 45131
Contact: Rene Chapot, Prof.         
Principal Investigator: Rene Chapot, Prof         
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Götz Thomalla, MD         
Principal Investigator: Jan Buhk         
Asklepios Klinik Altona, Fachbereich Neuroradiologie Recruiting
Hamburg, Germany, 22769
Contact: Bernd Eckert, Prof         
Universitätsklinikum Heidelberg Abteilung für Neuroradiologie Recruiting
Heidelberg, Germany, 69120
Contact: Markus Möhlenbruch, MD         
Universitätsklinikum Homburg Recruiting
Homburg, Germany, 66424
Contact: Wolfgang Reith, Prof.         
Klinikum Ingolstadt Not yet recruiting
Ingolstadt, Germany, 85049
Principal Investigator: Dr. Hendrik Janssen         
Uniklinik Köln Not yet recruiting
Köln, Germany, 50924
Contact: Christoph Kabbasch, MD         
Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie Recruiting
Mönchengladbach, Germany, 41063
Contact: Prof. Ringelstein         
Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg Recruiting
Oldenburg, Germany, 26122
Contact: Christian Mathys, MD         
Klinikum Osnabrück, Klinik für Neurologie Recruiting
Osnabrück, Germany, 49076
Contact: Lars Krause, MD         
Sub-Investigator: Stephan Lowens, MD         
St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen Recruiting
Solingen, Germany, 42697
Contact: Hannes Nordmeyer, MD         
Sponsors and Collaborators
Acandis GmbH
Investigators
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Principal Investigator: Götz Thomalla, MD Unversity Medical Center Hamburg-Eppendorf
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Responsible Party: Acandis GmbH
ClinicalTrials.gov Identifier: NCT03902444    
Other Study ID Numbers: ASSISTENT
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Additional relevant MeSH terms:
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Constriction, Pathologic
Pathological Conditions, Anatomical