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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Direct mechanical thrombectomy | Active Comparator | Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator. |
|
| Bridging therapy | Active Comparator | Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trevo and or Merci devices for stent retreival | Device | FDA approved devices for stent retrieval during mechanical thrombectomy |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed A Abdel Ghani, Master's | Alexandria University Faculty of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University Faculty of Medicine | Alexandria | 11523 | Egypt |
The data will be available upon request
30 days
The data will be available upon request
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D004617 | Embolism |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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Open-label, non-randomized, prospective, double-arm clinical trial
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|
| Penumbra system for stent aspiration | Device | FDA approved devices for stent aspiration during mechanical thrombectomy |
|
| recombinant tissue plasminogen activator | Drug | FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset |
|
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |