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

Stroke, Ischemic Clinical Trial

— VasIntervent  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04393025
• Other study ID #: FMASU MD 142/2016
• Status: Completed
• Phase: Phase 4
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: May 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2019
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke, Ischemic

Intervention

Device:
• Intracranial Stenting by Intracranial Stent Device
Large Intracranial Vessels with ICSD underwent catheter lab and IC stent is inserted

Drug:
• Optimum medical treatment
Optimum Medical treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Functional improvement of IC stented patients in comparison to medically treated	Functional assessment by modified Rankin Scale (mRS) for functional improvement	3 months
Primary	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	No Recurrent Ischemic stroke in stented ICSD patients	Clinical Assessment	6 months