A Phase 4 interventional study of Trevo and or Merci devices for stent retreival and Penumbra system for stent aspiration in Thrombectomy, Ischemic Stroke and Large-Artery Atherosclerosis (Embolus/Thrombosis), sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-03.
Sponsored by Alexandria University · Phase 4, Interventional, and Treatment
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.
2,593 studies on the registry are indexed under Ischemic Stroke; 930 are open to participants now.
This study's enrollment of 51 is below the median of 120 across 1,752 interventional studies indexed under Ischemic Stroke.
Browse Ischemic Stroke studies →Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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 · Device: Penumbra system for stent aspiration
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 · Device: Penumbra system for stent aspiration · Drug: recombinant tissue plasminogen activator
FDA approved devices for stent retrieval during mechanical thrombectomy
Also known as: No other names
FDA approved devices for stent aspiration during mechanical thrombectomy
FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset
Modified Rankin Scale score
A measurement of functional independence following ischemic stroke
Time frame: 3 months
Complication rate
The rate and type of complications occuring postoperatively
Time frame: within one week postoperatively
The National Institutes of Health Stroke Scale (NIHSS) score
A validated scale for assessment of neurological dysfunction associated with stroke
Time frame: at 24 hours postoperatively
Plan to share: Yes — The data will be available upon request
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
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Alexandria University