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

NCT ID: NCT03955835

Last Updated: 2021-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-09
• Study Completion Date: 2021-09-22

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.

Conditions

Acute Ischemic Stroke; Intracranial Stenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ACUTE

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.

Group Type: OTHER

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

Intervention Type: DEVICE

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.

Interventions

Treatment 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Acandis GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie

Hamburg, , Germany

Universitätsklinikum Heidelberg

Heidelberg, , Germany

Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes

Homburg, , Germany

Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie

Mönchengladbach, , Germany

Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg

Oldenburg, , Germany

Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik

Osnabrück, , Germany

Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik

Solingen, , Germany

Countries

Germany

Other Identifiers

ACUTE

Identifier Type: -

Identifier Source: org_study_id