Acandis Credo Intracranial Stent for Unsuccessful Recanalization After Thrombectomy (ACUTE) (ACUTE)
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ClinicalTrials.gov Identifier: NCT03955835 |
Recruitment Status :
Terminated
(CREDO stent is now CE-marked for rescue stenting (new indication).)
First Posted : May 20, 2019
Last Update Posted : October 21, 2021
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Condition or disease | Intervention/treatment | Phase |
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Acute Ischemic Stroke Intracranial Stenosis | Device: Treatment with Credo® stent together with the NeuroSpeed® PTA balloon catheter. | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 27 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 |
Actual Primary Completion Date : | September 22, 2021 |
Actual Study Completion Date : | September 22, 2021 |

Arm | Intervention/treatment |
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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.
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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. |
- 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).
- 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).
- 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 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 %
- 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)

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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 |
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

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
Germany | |
Universitätsklinikum Hamburg-Eppendorf | |
Hamburg, Germany, 20246 | |
Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie | |
Hamburg, Germany, 22763 | |
Universitätsklinikum Heidelberg | |
Heidelberg, Germany | |
Klinik für Diagnostische und Interventionelle Neuroradiologie, Universitätsklinikum des Saarlandes | |
Homburg, Germany, 66424 | |
Kliniken Maria Hilf GmbH Akademisches Lehrkrankenhaus der Uniklinik RWTH Aachen,Klinik für Diagnostische und Interventionelle Radiologie und Neuroradiologie | |
Mönchengladbach, Germany, 41063 | |
Institut für Radiologie und Neuroradiologie, Evangelisches Krankenhaus Oldenburg | |
Oldenburg, Germany, 26122 | |
Klinikum Osnabrück GmbH, Röntgen- und Strahlenklinik | |
Osnabrück, Germany, 49028 | |
Abteilung für interventionelle Neuroradiologie, radprax an der St. Lukas Klinik | |
Solingen, Germany, 42697 |
Responsible Party: | Acandis GmbH |
ClinicalTrials.gov Identifier: | NCT03955835 |
Other Study ID Numbers: |
ACUTE |
First Posted: | May 20, 2019 Key Record Dates |
Last Update Posted: | October 21, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Ischemic Stroke Stroke Cerebrovascular Disorders Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |