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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-06-30

Brief Summary

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

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Detailed Description

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

Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two armed medical study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intracranial Stenting

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

Group Type OTHER

Intracranial Stenting by Intracranial Stent Device

Intervention Type DEVICE

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

Aspirin+Clopidogrel

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

Group Type ACTIVE_COMPARATOR

Optimum medical treatment

Intervention Type DRUG

Optimum Medical treatment

Interventions

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Intracranial Stenting by Intracranial Stent Device

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

Intervention Type DEVICE

Optimum medical treatment

Optimum Medical treatment

Intervention Type DRUG

Other Intervention Names

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cardiac and wingspan IC stent device Clopidogrel 75 mg +Aspirin 161 mg

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No