Acute Ischemic Stroke, Intracranial Stenosis
Conditions
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.
Interventions
DEVICETreatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.
Self-expandable Credo® stent together with NeuroSpeed® PTA balloon catheter. Credo® and NeuroSpeed® are already CE approved products, for which within ACUTE an additional new indication shall be examined.
Sponsors
Acandis GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, interventional treatment, single-arm, open-label, multi-centre trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Co-Primary Technical Efficacy Endpoint | Assessed after interventional procedure | Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting). |
| Co-Primary Clinical Efficacy Endpoint | 90 +/- 10 days after stroke | Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2). |
| Primary Safety Endpoints | Within 18-36 hours after treatment | * 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Efficacy Endpoints | 90 +/- 10 days after stroke | * 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 % |
| Secondary Safety Endpoints | 90 +/- 10 days after stroke | * 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) |
Countries
Germany
Outcome results
None listed