Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2025-12-24 @ 10:37 PM
NCT ID:
NCT03955835
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03955835
Study Brief:
Protocol Section:
NCT03955835