Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA".
Primary Purpose
Stroke, Acute Ischemic
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mechanical thrombectomy
medical treatment
Sponsored by
About this trial
This is an interventional treatment trial for Stroke, Acute Ischemic
Eligibility Criteria
Inclusion Criteria:
- Age >18 years
- Cerebral infarction in anterior circulation involving occlusion of M2 MCA, proven by CTA
- With or without IV thrombolysis
- Access to endovascular treatment within 24 hours from onset.
Exclusion Criteria:
- Proven proximal occlusion of MCA.
- Disability prior to the stroke (mRS >3)
- Opposition of the patient or their family
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mechanical thrombectomy
medical managemnet
Arm Description
this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment.
this arm will include all patients who received medical treatment only, either anti-platelet or alteplase.
Outcomes
Primary Outcome Measures
Clinical neurological outcome
Clinical neurological outcome was evaluated at discharge (within one week from onset) and at 3 months by the neurologist in charge. by using National Institutes of Health Stroke Scale (NIHSS) Good clinical outcome at discharge was defined as a NIHSS score less than or equal to 2 or a decrease in NIHSS score greater than or equal to 10 points.
Secondary Outcome Measures
Functional outcome
Functional outcome will be assessed using Modified Rankin Scale (mRS) which measures the degree of disability after stroke.
Good functional outcome was defined as mRS less than 2 that will be assessed at one and three moth at discharge.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05091320
Brief Title
Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA".
Official Title
Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA" :a Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
November 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mechanical thrombectomy recently has revolutionized the treatment of stroke. Trials have demonstrated the superiority of mechanical thrombectomy in large vessel occlusions, such as in the intracranialinternal carotid artery and proximal, middle cerebral artery (M1), middle cerebral artery trunk (M1), have relatively high rates of revascularization and favorable clinical outcomes after MT. , However second-order branches of the middle cerebral artery (M2) occlusions (postbifurcation in the Sylvian fissure) were underrepresented or not represented in the trials. Posing a more significant technical challenge to the available endovascular devices because of the smaller size and tortuosity of these arteries and the greater likelihood of recanalization with intravenous thrombolysis, the overall risk-benefit remains uncertain.
Detailed Description
this study aims to:
compare efficacy of mechanical thrombectomy over medical treatment in occlusion of M2 division of MCA.
improve outcome of acute ischemic stroke.
The study will include all patients with AIS attending to emergency deparment with proven occlusion of M2 division of MCA, and deviding then into 2 groups:
Group 1 will receive medical treatment (rTPA if presented in the first 4 hours, and antiplatelet if passed time window for IVT) Group 2 will underwent mechanical thrombectomy (if accessible), and even after receiving medical treatment and not improved and comparing the outcomes of these 2 groups
c. Sample Size Calculation: Sample size was calculated using G*power, version 3.1.9.7. Estimation based on results of previous study which reported that, median (IQR) discharge NIHSS in mechanical thrombectomy group was 2 (0-4) compared to 1 (0-2) in medical management group giving medium effect size . With a power of 80% (using one-sided t-test, effect size = 0.65 and α of 0.5) the sample needed for the study was estimated to be 60 patients (30 in each group).
Study design:
All patients are subjected to the following: -
Enrolled patients were admitted to stroke units or intensive care units.
Intravenous t-PA was allowed if begun within < 4.5 hours after symptom onset.
Thrombectomy will be performed with any FDA approved thrombectomy device by the use of local anesthesia (general anesthesia will be discouraged).
Imaging
Patients presented with clinical picture and radiography suggestive of large vessel occlusion and who meet the proposed clinical criteria for EVT will be subjected to a comprehensive evaluation with:
Arterial imaging of the cerebral circulation with preferably with CTA or alternatively with magnetic resonance angiography to
Perfusion imaging with perfusion CT or with diffusion weighted imaging MRI can allow identification and quantification of the ischemic penumbra and, therefore, is useful for assessing patient eligibility for EVT in the extended time window.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Acute Ischemic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
case control
Masking
Participant
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mechanical thrombectomy
Arm Type
Active Comparator
Arm Description
this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment.
Arm Title
medical managemnet
Arm Type
Active Comparator
Arm Description
this arm will include all patients who received medical treatment only, either anti-platelet or alteplase.
Intervention Type
Drug
Intervention Name(s)
Mechanical thrombectomy
Intervention Description
Mechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke
Intervention Type
Drug
Intervention Name(s)
medical treatment
Intervention Description
medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet
Primary Outcome Measure Information:
Title
Clinical neurological outcome
Description
Clinical neurological outcome was evaluated at discharge (within one week from onset) and at 3 months by the neurologist in charge. by using National Institutes of Health Stroke Scale (NIHSS) Good clinical outcome at discharge was defined as a NIHSS score less than or equal to 2 or a decrease in NIHSS score greater than or equal to 10 points.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Functional outcome
Description
Functional outcome will be assessed using Modified Rankin Scale (mRS) which measures the degree of disability after stroke.
Good functional outcome was defined as mRS less than 2 that will be assessed at one and three moth at discharge.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age >18 years
Cerebral infarction in anterior circulation involving occlusion of M2 MCA, proven by CTA
With or without IV thrombolysis
Access to endovascular treatment within 24 hours from onset.
Exclusion Criteria:
Proven proximal occlusion of MCA.
Disability prior to the stroke (mRS >3)
Opposition of the patient or their family
12. IPD Sharing Statement
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Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA".
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