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
|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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||27 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective, interventional treatment, single-arm, open-label, multi-centre trial|
|Masking:||None (Open Label)|
|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|
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.
- 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)
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
|Hamburg, Germany, 20246|
|Asklepios Klinik Altona, Abteilung für Radiologie und Neuroradiologie|
|Hamburg, Germany, 22763|
|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|