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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03955835
Other study ID # ACUTE
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date August 9, 2019
Est. completion date September 22, 2021

Study information

Verified date October 2021
Source Acandis GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

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


Recruitment information / eligibility

Status Terminated
Enrollment 27
Est. completion date September 22, 2021
Est. primary completion date September 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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


Intervention

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.

Locations

Country Name City State
Germany Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie Hamburg
Germany Universitätsklinikum Hamburg-Eppendorf 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

Sponsors (1)

Lead Sponsor Collaborator
Acandis GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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 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 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
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