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

Ain Shams University

Status and phase: Completed; Phase 4

Conditions: Stroke, Ischemic

Treatments: Drug: Optimum medical treatment; Device: Intracranial Stenting by Intracranial Stent Device

Study type: Interventional

Funder types: Other

Identifiers

NCT04393025

FMASU MD 142/2016

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intracranial Stenting

Other group

Description:

25 Patients presented with recurrent Ischemic CVS with Large ICSD received ICS

Treatment:

Device: Intracranial Stenting by Intracranial Stent Device

Aspirin+Clopidogrel

Active Comparator group

Description:

25 Patients presented with recurrent Ischemic CVS with Large ICSD received optimal medical treatment

Treatment:

Drug: Optimum medical treatment