Health TrialsbyHealthPanel

Endovascular Treatment for Mild Ischemic Stroke Due to Acute Large Vessel Occlusion in the Anterior Circulation

ConditionsEndovascular TreatmentMild Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWen-huo Chen

About this trial

Explore the effectiveness and safety of emergency endovascular treatment in patients with mild ischemic stroke due to acute large vessel occlusion in the anterior circulation, identified through perfusion imaging.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years old;

Symptoms onset or last known well to randomization is within 24 hours.

Clinical diagnosis of acute ischemic stroke due to anterior circulation intracranial large vessel occlusion (LVO) (including intracranial internal carotid artery [ICA], middle cerebral artery [MCA] M1 segment, MCA M2 segment, with or without ipsilateral extracranial ICA occlusion) confirmed on Computerized tomography angiography (CTA) or Magnetic resonance imaging angiography (MRA) ;

Baseline NIHSS score <6 before randomization (including cases with NIHSS ≥6 at onset but improves before randomization);

Disqualifiers

Premorbid Rankin Scale (mRS) score ≥ 1;

Known allergy to iodine, heparin, anaesthesia, or other definite contraindication to receiving endovascular treatment (EVT) procedure;

Patient has severe or fatal co-morbidities that could interfere with outcome assessments and follow-up (such as malignant tumor, severe heart failure, or renal failure, or life expectancy less than 6 months);

Poorly controlled hypertension (systolic blood pressure >220 mmHg or diastolic blood pressure >120 mmHg);

Trial design

Design model

Parallel

Treatments tested in this trial

  • EVT

    Procedure/Surgery

    Interventionist choose the optimal EVT strategy and device based on the patient's condition and local guidelines. This may include, but not limited to, stent-retriever thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation and so on. The EVT regimen and relevant time points will be accurately recorded. The patient will receive the best medical treatment according to the local guidelines.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

The rate of excellent outcome

mRS score 0-1

Time frame
90±7 days

Secondary outcomes

1

The rate of good outcome

mRS score 0-2

Time frame
90±7 days
2

mRS shift

distribution of mRS scores

Time frame
90±7 days

Other outcomes

1

The rate of symptomatic intracranial hemorrhage

According to the Heidelberg criteria

Time frame
Within 48 hours
2

Rate of early neurological deterioration

An increase in NIHSS≥4 or an increase of ≥2 in any individual item

Time frame
Within 7 days
3

Mortality

Death

Time frame
90±7 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wen-huo Chen

Lead sponsor

Zhangzhou Municipal Hospital

Sponsor institution

Source ClinicalTrials.gov
Apply now