Acute Ischemic Stroke Clinical Trial
— ACUTEOfficial title:
Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)
Verified date | October 2021 |
Source | Acandis GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study objective is to evaluate the efficacy and safety of acute permanent stenting of symptomatic intracranial stenosis following unsuccessful recanalization by thrombectomy in acute ischemic stroke with large vessel occlusion using the self-expandable Credo® stent together with the NeuroSpeed® PTA balloon catheter.
Status | Terminated |
Enrollment | 27 |
Est. completion date | September 22, 2021 |
Est. primary completion date | September 22, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Acute ischemic stroke from large vessel occlusion (LVO) - Failed recanalization after treatment with thrombectomy, i.e. persistent occlusion of intracranial internal carotid artery (ICA), proximal segment (M1, M2) of the middle cerebral 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 judgement of 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 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 than atherosclerosis (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 K antagonists) - More than 3 attempts for recanalization of target lesion prior to the use of the study device. - Stenosis longer than the working length of the NeuroSpeed PTA balloon catheter. - Diameter of the healthy vessel proximal and distal to the stenosis prevents save treatment with the NeuroSpeed PTA balloon catheter or is outside the indicated range of the Credo stent. - Diameter of the target area is outside the indicated range of the Credo stent after predilation. - Contraindication against anti-platelet or anticoagulation therapy - Heavily calcified lesions that may prevent access or safe stent placement. - Pregnant and breastfeeding women |
Country | Name | City | State |
---|---|---|---|
Germany | Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie | Hamburg | |
Germany | Universitätsklinikum Hamburg-Eppendorf | Hamburg | |
Germany | Universitätsklinikum Heidelberg | Heidelberg | |
Germany | Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes | Homburg | |
Germany | Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie | Mönchengladbach | |
Germany | Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg | Oldenburg | |
Germany | Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik | Osnabrück | |
Germany | Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik | Solingen |
Lead Sponsor | Collaborator |
---|---|
Acandis GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Co-Primary Technical Efficacy Endpoint | Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting). | Assessed after interventional procedure | |
Primary | Co-Primary Clinical Efficacy Endpoint | Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2). | 90 +/- 10 days after stroke | |
Primary | Primary Safety Endpoints | Symptomatic intracranial hemorrhage (SICH) as defined in SITS-MOST (within 18-36 hours of treatment)
Device-related procedural complications: Dissection, perforation or rupture of the target vessel, embolism, stent thrombosis or occlusion, stent migration. |
Within 18-36 hours after treatment | |
Secondary | Secondary Efficacy Endpoints | Categorical shift in MRS 90 (±10) days after stroke
Functional health status and quality of life 90 (±10) days after stroke (EQ-5D) Infarct growth by 18-36 hours after stroke as compared to predicted infarct growth Frequency of residual stenosis > 50 % |
90 +/- 10 days after stroke | |
Secondary | Secondary Safety Endpoints | Ischemic stroke in downstream territory of the occluded vessel within 90 (±10) days after stroke
Parenchymal hemorrhage type 2 (PH-2) after 18-36 hours Embolization in new territories Mortality 90 (±10) days after stroke Death or dependency 90 (±10) days after stroke (MRS 4-6) |
90 +/- 10 days after stroke |
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