Direct Mechanical Thrombectomy Versus Bridging Therapy

Phase 4

Completed

• Conditions: Thrombectomy; Large-Artery Atherosclerosis (Embolus/Thrombosis); Ischemic Stroke
• Interventions: Device: Trevo and or Merci devices for stent retreival; Device: Penumbra system for stent aspiration; Drug: recombinant tissue plasminogen activator

• Registration Number: NCT05155540
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-07-01
• Study Completion: 2020-09-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Last Update Submitted: 2021-12-11
• Study First Posted: 2021-12-13
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Direct mechanical thrombectomy	Trevo and or Merci devices for stent retreival	Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator.
Direct mechanical thrombectomy	Penumbra system for stent aspiration	Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator.
Bridging therapy	Trevo and or Merci devices for stent retreival	Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg
Bridging therapy	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
Bridging therapy	recombinant tissue plasminogen activator	Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg

Primary Outcome Measures

Name	Time	Method
Complication rate	within one week postoperatively	The rate and type of complications occuring postoperatively
Modified Rankin Scale score	3 months	A measurement of functional independence following ischemic stroke

Secondary Outcome Measures

Name	Time	Method
The National Institutes of Health Stroke Scale (NIHSS) score	at 24 hours postoperatively	A validated scale for assessment of neurological dysfunction associated with stroke

Trial Locations

Locations (1)

Alexandria University Faculty of Medicine; 🇪🇬 Alexandria, Egypt