Direct Mechanical Thrombectomy Versus Bridging Therapy

Ischemic Stroke Clinical Trial

Official title:

A Comparative Study of The Efficacy and Safety of Direct Mechanical Thrombectomy Versus Bridging Therapy in Large Vessel Occlusion: An Egyptian Single-Center Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05155540
• Other study ID #: 0201218
• Status: Completed
• Phase: Phase 4
• 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
• 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.

Related Conditions & MeSH terms

• Atherosclerosis
• Ischemic Stroke
• Large-Artery Atherosclerosis (Embolus/Thrombosis)
• Thrombectomy
• Thrombosis

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