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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05155540
Other study ID # 0201218
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date July 1, 2019
Est. completion date September 1, 2020

Study information

Verified date December 2021
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 51
Est. completion date September 1, 2020
Est. primary completion date July 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Trevo and or Merci devices for stent retreival
FDA approved devices for stent retrieval during mechanical thrombectomy
Penumbra system for stent aspiration
FDA approved devices for stent aspiration during mechanical thrombectomy
Drug:
recombinant tissue plasminogen activator
FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset

Locations

Country Name City State
Egypt Alexandria University Faculty of Medicine Alexandria

Sponsors (1)

Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Rankin Scale score A measurement of functional independence following ischemic stroke 3 months
Primary Complication rate The rate and type of complications occuring postoperatively within one week postoperatively
Secondary 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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