Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA".

Mechanical Thrombectomy of Medium Sized Vessels "M2 of MCA" :a Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke, Acute Ischemic
• Intervention / Treatment: Drug: Mechanical thrombectomy; Drug: medical treatment

Detailed Description

this study aims to:

1. compare efficacy of mechanical thrombectomy over medical treatment in occlusion of M2 division of MCA.
2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Proven proximal occlusion of MCA.
2. Disability prior to the stroke (mRS >3)
3. Opposition of the patient or their family

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mechanical thrombectomy; this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment.	Drug: Mechanical thrombectomy; Mechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke; Drug: medical treatment; medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet
Active Comparator: medical managemnet; this arm will include all patients who received medical treatment only, either anti-platelet or alteplase.	Drug: medical treatment; medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): November 30, 2022
• Study Completion (Anticipated): November 30, 2022

Study Registration Dates

• First Submitted: September 23, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 25, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 12, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke
• Other Study ID Numbers: Neurointervintion and stroke

Drug and device information, study documents

• 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