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Trial record 1 of 1 for:    NCT03955835
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Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE) (ACUTE)

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ClinicalTrials.gov Identifier: NCT03955835
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Acandis GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Intracranial Stenosis Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter. Not Applicable

Detailed Description:
Prospective, interventional treatment, single-arm, open-label, multi-center trial.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 143 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, interventional treatment, single-arm, open-label, multi-centre trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE)
Actual Study Start Date : August 9, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Co-Primary Technical Efficacy Endpoint [ Time Frame: 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).

  2. Co-Primary Clinical Efficacy Endpoint [ Time Frame: 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).

  3. Primary Safety Endpoints [ Time Frame: 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.


Secondary Outcome Measures :
  1. Secondary Efficacy Endpoints [ Time Frame: 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 %

  2. Secondary Safety Endpoints [ Time Frame: 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955835


Locations
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Germany
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Götz Thomalla, MD    +49 40 7410- 50137    thomalla@uke.de   
Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie Recruiting
Hamburg, Germany, 22763
Contact: Prof. Dr. med. Bernd Eckert    040 181881 1811    b.eckert@asklepios.com   
Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany
Contact: Dr. Möhlenbruch    +49 6221 56-7566    Markus.Moehlenbruch@med.uni-heidelberg.de   
Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes Recruiting
Homburg, Germany, 66424
Contact: Prof. Dr. med. Wolfgang Reith    06841- 16-24302    wolfgang.reith@uks.eu   
Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie Not yet recruiting
Mönchengladbach, Germany, 41063
Contact: Prof. Dr. med. Adrian Ringelstein    02161 892 4417    adrian.ringelstein@mariahilf.de   
Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg Not yet recruiting
Oldenburg, Germany, 26122
Contact: PD Dr. med. Christian Mathys    0441 236-236    christian.mathys@evangelischeskrankenhaus.de   
Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik Recruiting
Osnabrück, Germany, 49028
Contact: Stephan Lowens    +49 541 405607502    stephan.lowens@klinikum-os.de   
Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik Recruiting
Solingen, Germany, 42697
Contact: Dr. med. Hannes Nordmeyer    0212-2489-2210    nordmeyer@gmx.com   
Sponsors and Collaborators
Acandis GmbH
More Information
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Responsible Party: Acandis GmbH
ClinicalTrials.gov Identifier: NCT03955835    
Other Study ID Numbers: ACUTE
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No