Endovascular Stenting of Medically Refractory ICASD (Clinical and Sonographic Study)
VasIntervent
1 other identifier
interventional
50
0 countries
N/A
Brief Summary
Cerebral Endovascular Stenting of medically refractory Intracranial Stenotic Blood Vessels with Recurrent Ischemic Strokes patients
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2016
Typical duration for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedFirst Submitted
Initial submission to the registry
December 16, 2019
CompletedFirst Posted
Study publicly available on registry
May 19, 2020
CompletedMay 19, 2020
May 1, 2020
2 years
December 16, 2019
May 14, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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
Functional improvement of IC stented patients in comparison to medically treated
Functional assessment by modified Rankin Scale (mRS) for functional improvement
3 months
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 Outcomes (1)
No Recurrent Ischemic stroke in stented ICSD patients
6 months
Study Arms (2)
Intracranial Stenting
OTHER25 Patients presented with recurrent Ischemic CVS with Large ICSD received ICS
Aspirin+Clopidogrel
ACTIVE COMPARATOR25 Patients presented with recurrent Ischemic CVS with Large ICSD received optimal medical treatment
Interventions
Large Intracranial Vessels with ICSD underwent catheter lab and IC stent is inserted
Optimum Medical treatment
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor of Neurology-Faculty of Medicine-ASU
Study Record Dates
First Submitted
December 16, 2019
First Posted
May 19, 2020
Study Start
June 1, 2016
Primary Completion
June 1, 2018
Study Completion
June 1, 2019
Last Updated
May 19, 2020
Record last verified: 2020-05