Last updated: October 14, 2021
Sponsor: Acandis GmbH
Overall Status: Terminated
Phase
N/A
Condition
Thrombosis
Stroke
Blood Clots
Treatment
N/AClinical Study ID
NCT03955835
ACUTE
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Acute ischemic stroke from large vessel occlusion (LVO)
- Failed recanalization after treatment with thrombectomy, i.e. persistent occlusion ofintracranial internal carotid artery (ICA), proximal segment (M1, M2) of the middlecerebral artery (MCA) (TICI 0-1)
- Small to moderate infarct core prior to initiation of thrombectomy (CT ASPECTS 6-10,DWI lesion < 70 ml)
- Suspected underlying stenosis of the occluded artery amenable to stenting by judgementof the treating neurointerventionalist
- Age 18- 80 years
- Informed consent (see below)
- Decision to perform angioplasty and stenting < 12 hours of symptom onset
- Previous passage of occlusion with microcatheter obtained
Exclusion
Exclusion Criteria:
- Large infarct core prior to initiation of thrombectomy (CT ASPECTS 0-5, DWI lesion > 70 ml)
- Vessel occlusion or stenosis of different known or suspected cause thanatherosclerosis (e.g. vasculitis)
- Pre-stroke disability (MRS > 2)
- Any sign of intracranial haemorrhage on brain imaging prior to thrombectomy
- Any sign of intracranial vessel perforation during thrombectomy
- Contraindication against treatment with double anti-platelet treatment
- Current effective use of oral anticoagulants (e.g. INR > 1.7 for Vitamin Kantagonists)
- More than 3 attempts for recanalization of target lesion prior to the use of the studydevice.
- Stenosis longer than the working length of the NeuroSpeed PTA balloon catheter.
- Diameter of the healthy vessel proximal and distal to the stenosis prevents savetreatment with the NeuroSpeed PTA balloon catheter or is outside the indicated rangeof the Credo stent.
- Diameter of the target area is outside the indicated range of the Credo stent afterpredilation.
- Contraindication against anti-platelet or anticoagulation therapy
- Heavily calcified lesions that may prevent access or safe stent placement.
- Pregnant and breastfeeding women
Study Design
Total Participants: 27
Study Start date:
August 09, 2019
Estimated Completion Date:
September 22, 2021
Study Description
Connect with a study center
Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie
Hamburg, 22763
GermanySite Not Available
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
GermanySite Not Available
Universitätsklinikum Heidelberg
Heidelberg,
GermanySite Not Available
Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes
Homburg, 66424
GermanySite Not Available
Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie
Mönchengladbach, 41063
GermanySite Not Available
Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg
Oldenburg, 26122
GermanySite Not Available
Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik
Osnabrück, 49028
GermanySite Not Available
Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik
Solingen, 42697
GermanySite Not Available

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