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

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

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

Study Overview

• Status: Completed
• Conditions: Stroke, Ischemic
• Intervention / Treatment: Device: Intracranial Stenting by Intracranial Stent Device; Drug: Optimum medical treatment

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2019

Study Registration Dates

• First Submitted: December 16, 2019
• First Submitted That Met QC Criteria: May 14, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 14, 2020
• Last Verified: May 1, 2020

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; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Clopidogrel
• Other Study ID Numbers: FMASU MD 142/2016

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