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

Phase 4

Completed

• Conditions: Stroke, Ischemic
• Interventions: Device: Intracranial Stenting by Intracranial Stent Device; Drug: Optimum medical treatment

• Registration Number: NCT04393025
• Lead Sponsor: Ain Shams University

Brief Summary

Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients

Detailed Description

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

Study Timeline

• Study Start: 2016-06
• Primary Completion: 2018-06
• Study Completion: 2019-06
• Study First Submitted: 2019-12-16
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-14
• Last Update Submitted: 2020-05-14
• Study First Posted: 2020-05-19
• Last Update Posted: 2020-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients age between 30-80 years.
2. 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).
3. 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).

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Exclusion Criteria

1. Patients previously stented at the target lesion or had extracranial stenosis.
2. Patient with acute stroke (within two weeks from the onset).
3. Complete occlusion of the artery on the imaging assessment.
4. Massive cerebral infarction (more than half the MCA territory), intracranial hemorrhage, epidural or subdural hemorrhage, and intracranial brain tumor on CT or MRI scans.
5. Contraindications to antithrombotic and/or anticoagulant therapies.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intracranial Stenting	Intracranial Stenting by Intracranial Stent Device	25 Patients presented with recurrent Ischemic CVS with Large ICSD received ICS
Aspirin+Clopidogrel	Optimum medical treatment	25 Patients presented with recurrent Ischemic CVS with Large ICSD received optimal medical treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
No Recurrent Ischemic stroke in stented ICSD patients	6 months	Clinical Assessment