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

NCT ID: NCT05091320

Last Updated: 2021-10-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2022-11-30

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:

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.

Conditions

Stroke, Acute Ischemic

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mechanical thrombectomy

this arm will include all patient underwent mechanical thrombectomy, either alone or after failure of medical treatment.

Group Type: ACTIVE_COMPARATOR

Mechanical thrombectomy

Intervention Type: DRUG

Mechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke

medical treatment

Intervention Type: DRUG

medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet

medical managemnet

this arm will include all patients who received medical treatment only, either anti-platelet or alteplase.

Group Type: ACTIVE_COMPARATOR

medical treatment

Intervention Type: DRUG

medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet

Interventions

Mechanical thrombectomy

Mechanical thrombectomy is interventional method and the first line management in large vessel occlusion in acute ischemic stroke

Intervention Type: DRUG

medical treatment

medical management of patient according guide lines, either alteplase if presented in it's time window, or anti-platelet

Intervention Type: DRUG

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

1. Proven proximal occlusion of MCA.

2. Disability prior to the stroke (mRS >3)

3. Opposition of the patient or their family

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mahmoud Nageeb

assistant lecurer of neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Neurointervintion and stroke

Identifier Type: -

Identifier Source: org_study_id