Ischemic Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis), Thrombectomy
Conditions
Keywords
ischemic stroke, Direct mechanical thrombectomy, Bridging therapy
Brief summary
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
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.
Interventions
DEVICETrevo and or Merci devices for stent retreival
FDA approved devices for stent retrieval during mechanical thrombectomy
DEVICEPenumbra system for stent aspiration
FDA approved devices for stent aspiration during mechanical thrombectomy
FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset
Sponsors
Alexandria University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-label, non-randomized, prospective, double-arm clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale score | 3 months | A measurement of functional independence following ischemic stroke |
| Complication rate | within one week postoperatively | The rate and type of complications occuring postoperatively |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The National Institutes of Health Stroke Scale (NIHSS) score | at 24 hours postoperatively | A validated scale for assessment of neurological dysfunction associated with stroke |
Countries
Egypt
Outcome results
None listed