Status:
COMPLETED
Endovascular Therapy in Acute Ischaemic Stroke Due to Large Vessel Occlusion
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
Queen Mary Hospital, Hong Kong
Ruttonjee Hospital, Hong Kong
Conditions:
Acute Ischaemic Stroke
Eligibility:
All Genders
Up to 80 years
Phase:
NA
Brief Summary
Aim of Study: 1. To develop a standardized patient selection criteria and imaging protocol for endovascular therapy in acute ischaemic stroke (AIS) 2. To create a local efficacy and safety database f...
Detailed Description
Our study aim to set a standard patient selection and imaging protocol based on previous positive trials for endovascular therapy in AIS patients. Local efficacy and safety data of the FDA mechanical ...
Eligibility Criteria
Inclusion
- Onset: ≤ 4.5 hours from symptoms onset
- Age \< 80
- Premorbid modified Rankin Score (mRS) ≤ 2
- NIHSS 8 - 29
- Clear and definite symptoms and signs suggesting stroke with hemiparesis as one of the presenting symptoms
- Plain CT brain showed no evidence of intracerebral haemorrhage and ASPECTS ≥ 7
- Multiphasic CT angiogram confirmed proximal vessel occlusion at internal carotid artery (ICA), carotid T junction, proximal middle cerebral artery (M1 segment to proximal M2 with loss of all M2 branches), proximal anterior cerebral artery (segment A1) or basilar artery
Exclusion
- Interventionist or angio-laboratory not available
- Neurological signs rapidly resolving
- NIHSS\>29
- Evidence of cerebral haemorrhage or subarachnoid haemorrhage on CT brain
- ASPECTS\<7
- Excessive tortuosity of the vessel precluding device delivery
- Known chronic renal failure with creatinine level \>250umol/L
- Known haemorrhagic diathesis
- Known coagulation factor deficiency
- Difficult blood pressure control with persistent systolic blood pressure \>185mg or diastolic blood pressure \>110mg despite aggressive blood pressure lowering therapy
- On anticoagulant and INR≥3
- On heparin in previous 48 hour and APTT\>2x of normal
- Platelet counts \<30
- Blood glucose \<2.7mmol/L
- Known severe allergies to contrast medium
- Seizure as presenting symptoms with post-ictal hemiparesis
- Life expectancy \< 3months
- Pregnant
Key Trial Info
Start Date :
September 17 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03328403
Start Date
September 17 2015
End Date
September 1 2019
Last Update
September 30 2019
Active Locations (1)
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1
Queen Mary Hospital
Hong Kong, Hong Kong