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

Not Applicable

Terminated

• Conditions: Intracranial Stenosis; Acute Ischemic Stroke
• Interventions: Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.

• Registration Number: NCT03955835
• Lead Sponsor: Acandis GmbH

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.

Study Timeline

• Study First Submitted: 2019-05-16
• Study First Submitted QC: 2019-05-17
• Study First Posted: 2019-05-20
• Study Start: 2019-08-09
• Primary Completion: 2021-09-22
• Study Completion: 2021-09-22
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ACUTE	Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter.	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.

Primary Outcome Measures

Name	Time	Method
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.
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).

Secondary Outcome Measures

Name	Time	Method
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)
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 %

Trial Locations

Locations (8)

Universitätsklinikum Heidelberg; 🇩🇪 Heidelberg, Germany

Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes; 🇩🇪 Homburg, Germany

Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik; 🇩🇪 Solingen, Germany

Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie; 🇩🇪 Hamburg, Germany

Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie; 🇩🇪 Mönchengladbach, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg; 🇩🇪 Oldenburg, Germany

Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik; 🇩🇪 Osnabrück, Germany