Direct Mechanical Thrombectomy Versus Bridging Therapy

Study Overview
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Brief Summary
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This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt.

Detailed Description
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This study compares the efficacy and safety of direct mechanical thrombectomy versus bridging therapy in patients with anterior circulation large vessel occlusion in a cohort of patients treated at the stroke unit of a single centre at Alexandria University in Egypt. In the first arm, 17 patients were recruited and underwent direct mechanical thrombectomy without receiving recombinant tissue plasminogen activator. In the bridging therapy arm, 34 patients received first tissue plasminogen activator then underwent direct mechanical thrombectomy. The efficacy was evaluated by the NIHSS improvement 24 hours following stroke onset and the modified Rankin scale 3 months following stroke. Safety was assessed by the procedural complications rate especially the hemorhagic transformation.

Official Title
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A Comparative Study of The Efficacy and Safety of Direct Mechanical Thrombectomy Versus Bridging Therapy in Large Vessel Occlusion: An Egyptian Single-Center Experience

Conditions
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Thrombectomy, Ischemic Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis)

Intervention / Treatment
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* Device: Trevo and or Merci devices for stent retreival
* Device: Penumbra system for stent aspiration
* Drug: recombinant tissue plasminogen activator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with anterior ischemic stroke due to large vessel occlusion. A previous autonomous modified Rankin Scale (mRS) of less than 2. A National Institutes of Health Stroke Scale (NIHSS)≥4 A groin puncture within 4.5 hours of the neurological deficit onset. Exclusion Criteria: Imaging documentation of intracranial haemorrhage A premorbid mRS score of 2 or more Absence of diffusion perfusion mismatch in CT perfusion.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Open-label, non-randomized, prospective, double-arm clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Direct mechanical thrombectomy<br>Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator. | Device: Trevo and or Merci devices for stent retreival<br>* FDA approved devices for stent retrieval during mechanical thrombectomy<br>* Other names: No other names;Device: Penumbra system for stent aspiration<br>* FDA approved devices for stent aspiration during mechanical thrombectomy<br>|
| Active Comparator: Bridging therapy<br>Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg | Device: Trevo and or Merci devices for stent retreival<br>* FDA approved devices for stent retrieval during mechanical thrombectomy<br>* Other names: No other names;Device: Penumbra system for stent aspiration<br>* FDA approved devices for stent aspiration during mechanical thrombectomy<br>Drug: recombinant tissue plasminogen activator<br>* FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale score | A measurement of functional independence following ischemic stroke | 3 months | 
| Complication rate | The rate and type of complications occuring postoperatively | within one week postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The National Institutes of Health Stroke Scale (NIHSS) score | A validated scale for assessment of neurological dysfunction associated with stroke | at 24 hours postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, Direct mechanical thrombectomy, Bridging therapy