Skip to main content
OpenTrials
Completed

NCT Number: NCT04393025

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke, Ischemic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intracranial Stenting by Intracranial Stent Device

Device

Large Intracranial Vessels with ICSD underwent catheter lab and IC stent is inserted

Other names: cardiac and wingspan IC stent device

Optimum medical treatment

Drug

Optimum Medical treatment

Other names: Clopidogrel 75 mg +Aspirin 161 mg

Primary outcomes

  1. Clinical improvement of IC stented patients in comparison to medically treated

    Time frame: 3 months

    clinical assessment by National Institute of Health Stroke Scale (NIHSS) for clinical impr

  2. Functional improvement of IC stented patients in comparison to medically treated

    Time frame: 3 months

    Functional assessment by modified Rankin Scale (mRS) for functional improvement

  3. Blood flow velocity accrossed Stenotic Large IC Vessels in comparison to medically treated

    Time frame: 3 months

    Transcranial doppler (TCD) assessment of Mean Flow Velocity (MFV) across IC vessels

Secondary outcomes

  1. No Recurrent Ischemic stroke in stented ICSD patients

    Time frame: 6 months

    Clinical Assessment

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Acronym: VasIntervent

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
May 19, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.