Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)

Acandis

Status: Terminated

Conditions: Intracranial Stenosis; Acute Ischemic Stroke

Treatments: Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.

Study type: Interventional

Funder types: Industry

Identifiers

NCT03955835

ACUTE

Details and patient eligibility

About

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.

Full description

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

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

ACUTE

Other group

Description:

Patients with acute ischemic stroke and proven large vessel occlusion (e.g. intracranial internal carotid artery or middle cerebral artery) with unsuccessful recanalization after endovascular treatment with mechanical thrombectomy and suspected underlying stenosis of the occluded intracranial artery amenable to stenting based on judgment by the treating neurointerventionalist.

Treatment:

Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.