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Completed

NCT Number: NCT05155540

Direct Mechanical Thrombectomy Versus Bridging Therapy

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.

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Key information

Conditions

Thrombectomy Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism Embolism and Thrombosis Ischemic Stroke Large-Artery Atherosclerosis (Embolus/Thrombosis) Nervous System Diseases Stroke Thrombosis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alexandria University Faculty of Medicine

Alexandria, 11523, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trevo and or Merci devices for stent retreival

Device

FDA approved devices for stent retrieval during mechanical thrombectomy

Other names: No other names

Penumbra system for stent aspiration

Device

FDA approved devices for stent aspiration during mechanical thrombectomy

recombinant tissue plasminogen activator

Drug

FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset

Primary outcomes

  1. Modified Rankin Scale score

    Time frame: 3 months

    A measurement of functional independence following ischemic stroke

  2. Complication rate

    Time frame: within one week postoperatively

    The rate and type of complications occuring postoperatively

Secondary outcomes

  1. The National Institutes of Health Stroke Scale (NIHSS) score

    Time frame: at 24 hours postoperatively

    A validated scale for assessment of neurological dysfunction associated with stroke

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 13, 2021
Registry last updated
Jan 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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