CASES-EXTENDED: long-term follow-up of patients after stroke

Long term follow-up of patients with acute carotid tandem lesions of presumed atherosclerotic origin - Long term outcomes of Carotid Artery Stenting during Endovascular treatment of acute ischemic Stroke (CASES_EXTENDED)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON57845

Enrollment

250

Registered

2025-03-03

Start date

2025-10-27

Completion date

Unknown

Last updated

2025-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke, tandem lesion, large vessel occlusion, carotid stenosis, atherosclerose

Interventions

There will be no additional study related interventions in CASES_EXTENDED. Patients that have been enrolled in the CASES trial will be included and follow-up of these patients will be extended. Patien

receive&nbsp

regular rehabilitation&nbsp

therapy&nbsp

according&nbsp

to&nbsp

prevailing&nbsp

guidelines

the rehabilitation process will&nbsp

not be affected by this study.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants of CASES study (NL79046.078.23) 

Exclusion criteria

Exclusion criteria: Patients that did not consent to be approached for further research when signing the informed consent of the CASES trial (NL79046.078.23) 

Design outcomes

Primary

Measure	Time frame
Immediate carotid artery stenting during EVT outcomes: Primary safety and efficacy outcomes: recurrent stroke, vascular events, myocardial infarctions or death after 3-, 12- and 24 months. Duplex ultrasound of the ipsilateral carotid artery will be at 24-months post stroke to assess stent patency. Long Term recovery outomes Various aspects of functional recovery will be adopted encompassing the WHO International Classification of Function domains of body functions and structures: sensorimotor and cognitive function, activity: upper and lower limb capacity and ADL and participation (impact on daily life). The main outcome parameters will be the Fugl-Meyer, arm (FM-UE) and leg section (FM-LE), Amsterdam Cognition scale (AMS), Action research arm test (ARAT), Functional ambulation categories (FAC), 10- meter walk test (10MWT), trail making test (TMT), and Mini-balance evaluation systems test (mini-BEST)ICF Domain: Body function & Structures:Brunnström Fugl-Meyer assessment for synergy of the upper and lower extremity (FM-UE and FM-LE)The Amsterdam Cognition Scan online neuropsychological test battery  ICF Domain: Activities/Capacity:Action Research Arm Test (ARAT) for the upper extremityFunctional Ambulatory Categories (FAC)Ten (10) meter walking test at comfortable speed (10MWT)Mini-balance evaluation systems test (mini-BEST).	—

Measure

Time frame

Immediate carotid artery stenting during EVT outcomes: Primary safety and efficacy outcomes: recurrent stroke, vascular events, myocardial infarctions or death after 3-, 12- and 24 months. Duplex ultrasound of the ipsilateral carotid artery will be at 24-months post stroke to assess stent patency. Long Term recovery outomes Various aspects of functional recovery will be adopted encompassing the WHO International Classification of Function domains of body functions and structures: sensorimotor and cognitive function, activity: upper and lower limb capacity and ADL and participation (impact on daily life). The main outcome parameters will be the Fugl-Meyer, arm (FM-UE) and leg section (FM-LE), Amsterdam Cognition scale (AMS), Action research arm test (ARAT), Functional ambulation categories (FAC), 10- meter walk test (10MWT), trail making test (TMT), and Mini-balance evaluation systems test (mini-BEST)ICF Domain: Body function & Structures:Brunnström Fugl-Meyer assessment for synergy of the upper and lower extremity (FM-UE and FM-LE)The Amsterdam Cognition Scan online neuropsychological test battery  ICF Domain: Activities/Capacity:Action Research Arm Test (ARAT) for the upper extremityFunctional Ambulatory Categories (FAC)Ten (10) meter walking test at comfortable speed (10MWT)Mini-balance evaluation systems test (mini-BEST). 

—

Secondary

Measure	Time frame
Baseline clinical and neuroimaging parameters.Baseline demographics, medical history, comorbidities and vascular risk factors will retrospectively be recorded (such as but not limited to: age, sex, pre-stroke mRS, previous stroke, previous myocardial infarction, hypertension, hyperlipidemia, diabetes mellitus, atrial fibrillation, peripheral vascular disease, smoking status). Medication at baseline and during follow-up will be assessed (such as but not limited to: antiplatelet therapy, anticoagulant therapy, antihypertensive treatment, lipid lowering drugs). NIHSS score at stroke onset, 24 hours and 5-7 days post stroke, Glascow Coma Score (GCS), Laboratory results (such as but not limited to: renal and liver function, glucose, thrombocytes, CRP), Imaging characteristics (such as but not limited to ASPECTS score on non-contrast CT, infarct core volume, penumbra volume, location of intracranial occlusion on CTA and Digital subtraction Angiography (DSA), and expanded treatment in cerebral infarction (eTICI) score after EVT. Standard clinimetry performed in hospital setting including: MOCA, FAC,10m WT when FAC>3, BI, Trunk Control Test/Motricity Index when NIHSS item 4,5 are >0, Shoulder Abduction/Finger Extension (SAFE) Y/N, HADS and GDS.Functional outcome assessmentMotricity Index-arm and leg (MI)O-Letter Cancellation Test (LCT)Erasmus MC Modification of the (revised) Nottingham Sensory Assessment (EmNSA)Trunk Impairment Scale (TIS)Berg Balance Scale (BBS) (for patient with a FAC<3) Dynamic Gait Index (DGI) (for patient with a FAC>2)6minWT (for patient with a FAC>2)National Institute of Health Stroke Scale (NIHSS)Motor and cognitive performance assays:Finger extensionDrinking taskGrip strength as measured with a hand-held dynamometer, ELINK handkit, biometrics ltd, Newport, UK ((MDR class 1 certified).  Pinch grip strength as measured with force transducer, ELINK handkit, biometrics ltd, Newport, UK (MDR cla	—

Measure

Time frame

Baseline clinical and neuroimaging parameters.Baseline demographics, medical history, comorbidities and vascular risk factors will retrospectively be recorded (such as but not limited to: age, sex, pre-stroke mRS, previous stroke, previous myocardial infarction, hypertension, hyperlipidemia, diabetes mellitus, atrial fibrillation, peripheral vascular disease, smoking status). Medication at baseline and during follow-up will be assessed (such as but not limited to: antiplatelet therapy, anticoagulant therapy, antihypertensive treatment, lipid lowering drugs). NIHSS score at stroke onset, 24 hours and 5-7 days post stroke, Glascow Coma Score (GCS), Laboratory results (such as but not limited to: renal and liver function, glucose, thrombocytes, CRP), Imaging characteristics (such as but not limited to ASPECTS score on non-contrast CT, infarct core volume, penumbra volume, location of intracranial occlusion on CTA and Digital subtraction Angiography (DSA), and expanded treatment in cerebral infarction (eTICI) score after EVT. Standard clinimetry performed in hospital setting including: MOCA, FAC,10m WT when FAC>3, BI, Trunk Control Test/Motricity Index when NIHSS item 4,5 are >0, Shoulder Abduction/Finger Extension (SAFE) Y/N, HADS and GDS.Functional outcome assessmentMotricity Index-arm and leg (MI)O-Letter Cancellation Test (LCT)Erasmus MC Modification of the (revised) Nottingham Sensory Assessment (EmNSA)Trunk Impairment Scale (TIS)Berg Balance Scale (BBS) (for patient with a FAC<3) Dynamic Gait Index (DGI) (for patient with a FAC>2)6minWT (for patient with a FAC>2)National Institute of Health Stroke Scale (NIHSS)Motor and cognitive performance assays:Finger extensionDrinking taskGrip strength as measured with a hand-held dynamometer, ELINK handkit, biometrics ltd, Newport, UK ((MDR class 1 certified).  Pinch grip strength as measured with force transducer, ELINK handkit, biometrics ltd, Newport, UK (MDR cla

—

Countries

Netherlands

Contacts

Public ContactF Roelofs

Amsterdam UMC

f.roelofs@amsterdamumc.nl0205669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)