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

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.

Study Overview

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

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf
  • Hamburg, Germany, 22763
    • Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie
  • Heidelberg, Germany
    • Universitätsklinikum Heidelberg
  • Homburg, Germany, 66424
    • Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes
  • Mönchengladbach, Germany, 41063
    • Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie
  • Oldenburg, Germany, 26122
    • Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg
  • Osnabrück, Germany, 49028
    • Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik
  • Solingen, Germany, 42697
    • Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-Primary Technical Efficacy Endpoint	Technical success defined as successful recanalization of the occluded vessel (TICI 2b-3) at the end of the procedure (successful PTA + permanent stenting).	Assessed after interventional procedure
Co-Primary Clinical Efficacy Endpoint	Good clinical outcome 90 (±10) days after stroke defined as a score of 0-2 on the modified Ranking Score (MRS 0-2).	90 +/- 10 days after stroke
Primary Safety Endpoints	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.	Within 18-36 hours after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Efficacy Endpoints	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 %	90 +/- 10 days after stroke
Secondary Safety Endpoints	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)	90 +/- 10 days after stroke

Collaborators and Investigators

• Sponsor: Acandis GmbH

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2019
• Primary Completion (Actual): September 22, 2021
• Study Completion (Actual): September 22, 2021

Study Registration Dates

• First Submitted: May 16, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 20, 2019

Study Record Updates

• Last Update Posted (Actual): October 21, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: ACUTE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No