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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04393025
Acronym
VasIntervent
Enrollment
50
Registered
2020-05-19
Start date
2016-06-30
Completion date
2019-06-30
Last updated
2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke, Ischemic

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

Interventions

DEVICEIntracranial Stenting by Intracranial Stent Device

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

DRUGOptimum medical treatment

Optimum Medical treatment

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Two armed medical study

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Clinical improvement of IC stented patients in comparison to medically treated3 monthsclinical assessment by National Institute of Health Stroke Scale (NIHSS) for clinical impr
Functional improvement of IC stented patients in comparison to medically treated3 monthsFunctional assessment by modified Rankin Scale (mRS) for functional improvement
Blood flow velocity accrossed Stenotic Large IC Vessels in comparison to medically treated3 monthsTranscranial doppler (TCD) assessment of Mean Flow Velocity (MFV) across IC vessels

Secondary

MeasureTime frameDescription
No Recurrent Ischemic stroke in stented ICSD patients6 monthsClinical Assessment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026