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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 11523
    • Alexandria University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Direct mechanical thrombectomy; Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator.	Device: Trevo and or Merci devices for stent retreival; FDA approved devices for stent retrieval during mechanical thrombectomy; Other Names: No other names; Device: Penumbra system for stent aspiration; FDA approved devices for stent aspiration during mechanical thrombectomy
Active Comparator: Bridging therapy; Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg	Device: Trevo and or Merci devices for stent retreival; FDA approved devices for stent retrieval during mechanical thrombectomy; Other Names: No other names; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alexandria University
• Investigators: Principal Investigator: Mohamed A Abdel Ghani, Master's, Alexandria University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: December 3, 2021
• First Submitted That Met QC Criteria: December 3, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: ischemic stroke; Bridging therapy; Direct mechanical thrombectomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Embolism and Thrombosis; Stroke; Ischemic Stroke; Thrombosis; Atherosclerosis; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator; Plasminogen
• Other Study ID Numbers: 0201218

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon request
• IPD Sharing Time Frame: 30 days
• IPD Sharing Access Criteria: The data will be available upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes