Endovascular Stenting of Medically Refractory ICASD (Clinical and Sonographic Study)

Study Overview
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Brief Summary
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Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients

Detailed Description
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Fifty patients were enrolled with 25 underwent Intracranial Stenting 25 received optimal medicall treatment without stenting and comparative study of primary outcome was conducted

Official Title
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Endovascular Stenting of Medically Refractory Intracranial Arterial Stenotic (ICAS) Disease (Clinical and Sonographic Study)

Conditions
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Stroke, Ischemic

Intervention / Treatment
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* Device: Intracranial Stenting by Intracranial Stent Device
* Drug: Optimum medical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age between 30-80 years. Symptomatic ICAS: presented with TIA or stroke, attributed to 70%-99% stenosis of a major intracranial artery: Internal carotid artery (ICA), middle cerebral artery (MCA) [M1segment], vertebral artery (VA), or basilar artery (BA). Patient with recurrent TIA or stroke despite medical therapy, including anti-coagulation or antiplatelet and control of all vascular risk factors (DM, HTN and Hyperlipidemia). Exclusion Criteria: Patients previously stented at the target lesion or had extracranial stenosis. Patient with acute stroke (within two weeks from the onset). Complete occlusion of the artery on the imaging assessment. Massive cerebral infarction (more than half the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI scans. Contraindications to antithrombotic and/or anticoagulant therapies.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two armed medical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Intracranial Stenting<br>25 Patients presented with recurrent Ischemic CVS with Large ICSD received ICS | Device: Intracranial Stenting by Intracranial Stent Device<br>* Large Intracranial Vessels with ICSD underwent catheter lab and IC stent is inserted<br>* Other names: cardiac and wingspan IC stent device;|
| Active Comparator: Aspirin+Clopidogrel<br>25 Patients presented with recurrent Ischemic CVS with Large ICSD received optimal medical treatment | Drug: Optimum medical treatment<br>* Optimum Medical treatment<br>* Other names: Clopidogrel 75 mg +Aspirin 161 mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement of IC stented patients in comparison to medically treated | clinical assessment by National Institute of Health Stroke Scale (NIHSS) for clinical impr | 3 months | 
| Functional improvement of IC stented patients in comparison to medically treated | Functional assessment by modified Rankin Scale (mRS) for functional improvement | 3 months | 
| Blood flow velocity accrossed Stenotic Large IC Vessels in comparison to medically treated | Transcranial doppler (TCD) assessment of Mean Flow Velocity (MFV) across IC vessels | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No Recurrent Ischemic stroke in stented ICSD patients | Clinical Assessment | 6 months |