NCT05155540

Direct Mechanical Thrombectomy Versus Bridging Therapy

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Trevo and or Merci devices for stent retreival	FDA approved devices for stent retrieval during mechanical thrombectomy
DEVICE	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

Timeline

• Start date: 2019-07-01
• Primary completion: 2020-07-01
• Completion: 2020-09-01
• First posted: 2021-12-13
• Last updated: 2022-01-03

Locations

1 site across 1 country: Egypt

Regulatory

• FDA-regulated drug study
• FDA-regulated device study