AcandiS Stenting of Intracranial STENosis - regisTry

Intracranial Stenosis Clinical Trial

— ASSISTENT  

Official title:

AcandiS Stenting of Intracranial STENosis - regisTry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03902444
• Other study ID #: ASSISTENT
• Status: Recruiting
• Start date: May 2016
• Est. completion date: October 2025

Study information

• Verified date: January 2023
• Source: Acandis GmbH
• Contact: Acandis GmbH
• Phone: +49 723 1155 00
• Email: info[@]acandis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: October 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Intracranial Stenosis

Intervention

Device:
• Credo® Stent, NeuroSpeed® PTA balloon catheter
a self-expanding stent is used together with a PTA balloon catheter

Locations

Country	Name	City	State
Germany	Universitätsklinikum Knappschaftskrankenhaus Bochum	Bochum
Germany	Universitätsklinikum Düsseldorf Institut für Diagnostische und Interventionelle Radiologie Abteilung Neuroradiologie	Düsseldorf
Germany	Alfried Krupp Krankenhaus Essen, Klinik für Neuroradiologie	Essen
Germany	Institut für Diagnostische und Interventionelle Neuroradiologie Universitätsmedizin Göttingen	Göttingen
Germany	Asklepios Klinik Altona, Fachbereich Neuroradiologie	Hamburg
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Heidelberg Abteilung für Neuroradiologie	Heidelberg
Germany	Universitätsklinikum Homburg	Homburg
Germany	Klinikum Ingolstadt	Ingolstadt
Germany	Uniklinik Köln	Köln
Germany	Otto-von-Guericke-Universität Magdeburg Universitätsklinik für Neuroradiologie	Magdeburg
Germany	Kliniken Maria Hilf GmbH Mönchengladbach, Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie	Mönchengladbach
Germany	Evangelisches Krankenhaus Oldenburg; Medizinischer Campus Universität Oldenburg	Oldenburg
Germany	Klinikum Osnabrück, Klinik für Neurologie	Osnabrück
Germany	KLINIKUM VEST GMBH Knappschaftskrankenhaus Klinik für Radiologie und Neuroradiologie	Recklinghausen
Germany	St. Lukas Klinik GmbH, radprax MVZ GmbH Solingen	Solingen

Sponsors (1)

Lead Sponsor	Collaborator
Acandis GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Technical Success	• Technical Success	During interventional procedure
Primary	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
Primary	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
Primary	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	Number of Patients with Dissection of the target vessel		During interventional procedure
Secondary	Number of Patients with Occlusion of the target vessel		30 days after the interventional procedure
Secondary	Number of Patients with Myocardial infarction		30 days after the interventional procedure
Secondary	Number of Patients with Severe extracranial hemorrhage (requiring surgical treatment or transfusion)		30 days after the interventional procedure