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Direct Mechanical Thrombectomy Versus Bridging Therapy

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Trevo and or Merci devices for stent retreival
Penumbra system for stent aspiration
recombinant tissue plasminogen activator
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombectomy focused on measuring ischemic stroke, Direct mechanical thrombectomy, Bridging therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Alexandria University Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Direct mechanical thrombectomy

Bridging therapy

Arm Description

Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous 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

Outcomes

Primary Outcome Measures

Modified Rankin Scale score
A measurement of functional independence following ischemic stroke
Complication rate
The rate and type of complications occuring postoperatively

Secondary Outcome Measures

The National Institutes of Health Stroke Scale (NIHSS) score
A validated scale for assessment of neurological dysfunction associated with stroke

Full Information

First Posted
December 3, 2021
Last Updated
December 11, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05155540
Brief Title
Direct Mechanical Thrombectomy Versus Bridging Therapy
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombectomy, Ischemic Stroke, Large-Artery Atherosclerosis (Embolus/Thrombosis)
Keywords
ischemic stroke, Direct mechanical thrombectomy, Bridging therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open-label, non-randomized, prospective, double-arm clinical trial
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Direct mechanical thrombectomy
Arm Type
Active Comparator
Arm Description
Direct mechanical thrombectomy performed within 4.5 of stroke onset without giving intravenous recombinant tissue plasminogen activator.
Arm Title
Bridging therapy
Arm Type
Active Comparator
Arm Description
Mechanical thrombectomy performed within 4.5 of stroke onset after giving intravenous recombinant tissue plasminogen activator at a dose of 0.9 mg/Kg
Intervention Type
Device
Intervention Name(s)
Trevo and or Merci devices for stent retreival
Other Intervention Name(s)
No other names
Intervention Description
FDA approved devices for stent retrieval during mechanical thrombectomy
Intervention Type
Device
Intervention Name(s)
Penumbra system for stent aspiration
Intervention Description
FDA approved devices for stent aspiration during mechanical thrombectomy
Intervention Type
Drug
Intervention Name(s)
recombinant tissue plasminogen activator
Intervention Description
FDA approved drug for treatment of acute ischemic stroke within 4.5 hours of strokeonset
Primary Outcome Measure Information:
Title
Modified Rankin Scale score
Description
A measurement of functional independence following ischemic stroke
Time Frame
3 months
Title
Complication rate
Description
The rate and type of complications occuring postoperatively
Time Frame
within one week postoperatively
Secondary Outcome Measure Information:
Title
The National Institutes of Health Stroke Scale (NIHSS) score
Description
A validated scale for assessment of neurological dysfunction associated with stroke
Time Frame
at 24 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed A Abdel Ghani, Master's
Organizational Affiliation
Alexandria University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University Faculty of Medicine
City
Alexandria
ZIP/Postal Code
11523
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Direct Mechanical Thrombectomy Versus Bridging Therapy

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