Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Acute Ischemic Stroke
- Sponsor
- Acandis GmbH
- Enrollment
- 27
- Locations
- 8
- Primary Endpoint
- Co-Primary Clinical Efficacy Endpoint
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Co-Primary Clinical Efficacy Endpoint
Time Frame: 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
Time Frame: 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.
Co-Primary Technical Efficacy Endpoint
Time Frame: 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).
Secondary Outcomes
- Secondary Safety Endpoints(90 +/- 10 days after stroke)
- Secondary Efficacy Endpoints(90 +/- 10 days after stroke)