Clinical trial NCT03955835: Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)
Official title: Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Acute Ischemic Stroke
Intracranial Stenosis
Lead sponsor: Acandis GmbH
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, interventional treatment, single-arm, open-label, multi-centre trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Prospective, interventional treatment, single-arm, open-label, multi-center trial.

Eligibility criteria: 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

Primary outcomes:
measure: Co-Primary Technical Efficacy Endpoint
timeFrame: Assessed after interventional procedure
measure: Co-Primary Clinical Efficacy Endpoint
timeFrame: 90 +/- 10 days after stroke
measure: Primary Safety Endpoints
timeFrame: Within 18-36 hours after treatment
Secondary outcomes:
measure: Secondary Efficacy Endpoints
timeFrame: 90 +/- 10 days after stroke
measure: Secondary Safety Endpoints
timeFrame: 90 +/- 10 days after stroke
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hamburg
country: Germany
facility: Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Homburg
country: Germany
facility: Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes
city: Mönchengladbach
country: Germany
facility: Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie
city: Oldenburg
country: Germany
facility: Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg
city: Osnabrück
country: Germany
facility: Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik
city: Solingen
country: Germany
facility: Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik
Study officials:
References: