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Mechanical thrombectomy recently has revolutionized the treatment of stroke. Trials have demonstrated the superiority of mechanical thrombectomy in large vessel occlusions, such as in the intracranialinternal carotid artery and proximal, middle cerebral artery (M1), middle cerebral artery trunk (M1), have relatively high rates of revascularization and favorable clinical outcomes after MT. , However second-order branches of the middle cerebral artery (M2) occlusions (postbifurcation in the Sylvian fissure) were underrepresented or not represented in the trials. Posing a more significant technical challenge to the available endovascular devices because of the smaller size and tortuosity of these arteries and the greater likelihood of recanalization with intravenous thrombolysis, the overall risk-benefit remains uncertain.
this study aims to:
The study will include all patients with AIS attending to emergency deparment with proven occlusion of M2 division of MCA, and deviding then into 2 groups:
Group 1 will receive medical treatment (rTPA if presented in the first 4 hours, and antiplatelet if passed time window for IVT) Group 2 will underwent mechanical thrombectomy (if accessible), and even after receiving medical treatment and not improved and comparing the outcomes of these 2 groups
c. Sample Size Calculation: Sample size was calculated using G*power, version 3.1.9.7. Estimation based on results of previous study which reported that, median (IQR) discharge NIHSS in mechanical thrombectomy group was 2 (0-4) compared to 1 (0-2) in medical management group giving medium effect size . With a power of 80% (using one-sided t-test, effect size = 0.65 and α of 0.5) the sample needed for the study was estimated to be 60 patients (30 in each group).
Study design:
All patients are subjected to the following: -
Imaging
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical thrombectomy | Active Comparator | this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment. |
|
| medical managemnet | Active Comparator | this arm will include all patients who received medical treatment only, either anti-platelet or alteplase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical thrombectomy | Drug | Mechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical neurological outcome | Clinical neurological outcome was evaluated at discharge (within one week from onset) and at 3 months by the neurologist in charge. by using National Institutes of Health Stroke Scale (NIHSS) Good clinical outcome at discharge was defined as a NIHSS score less than or equal to 2 or a decrease in NIHSS score greater than or equal to 10 points. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Functional outcome | Functional outcome will be assessed using Modified Rankin Scale (mRS) which measures the degree of disability after stroke. Good functional outcome was defined as mRS less than 2 that will be assessed at one and three moth at discharge. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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case control
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| medical treatment | Drug | medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |