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CompletedNCT05203887Updated Apr 18, 2024

Short- and Long-term Outcomes of Stenting for Symptomatic Intracranial Arterial Stenosis: a Cohort Study

An observational study in Intracranial Atherosclerosis, sponsored by Sohag University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Sohag University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
43
Ages
18 Years to 85 Years
Sex
All
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Study summary

The purpose of this study is to assess short and long term outcomes of stenting for symptomatic intracranial arterial stenosis.

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Conditions studied

  • Intracranial Atherosclerosis
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In context

Intracranial Arteriosclerosis

93 studies on the registry are indexed under Intracranial Arteriosclerosis; 41 are open to participants now.

This study's enrollment of 43 is below the median of 275 across 32 observational studies indexed under Intracranial Arteriosclerosis.

Browse Intracranial Arteriosclerosis studies →

Lead sponsor

Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with symptomatic intracranial arterial stenosis caused by intracranial atherosclerosis

Inclusion criteria

  • Participants had a symptomatic intracranial stenosis of 70-99 percentage (%) with a lesion length of ≤15 mm and target vessel diameter of ≥2.0 mm in the intracranial internal carotid, middle cerebral, intracranial vertebral or basilar arteries and the measurements of stenosis will be made on magnetic resonance angiography (MRA) using the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial method and confirmed by digital subtraction angiography (DSA).
  • Presented with transient ischemic attack (TIA) or stroke within the past 12 months attributed to the stenosis.

Exclusion criteria

Exclusion Criteria:

  • Participants with acute infarctions within the past 3 weeks.
  • Severe arterial tortuosity prevents the deployment of endovascular devices.
  • Non-atherosclerotic lesion on magnetic resonance imaging (MRI), embolic or perforator stroke on MRI or computerized tomography (CT).
  • A baseline modified Rankin Scale (mRS) score of >3.
  • Massive cerebral infarction (>1/2 middle cerebral artery (MCA) territory), intracranial hemorrhage, epidural or sub-dural hemorrhage, and intracranial brain tumor on CT or MRI scan.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
43 participants (actual)
Target follow-up
12 Months
Patient registry
Yes
06

What researchers measure

Primary outcomes

  1. Cerebrovascular events

    Any stroke (including ischemic or hemorrhagic stroke) or TIA after stenting within the territory of the target vessel.

    Time frame: 30 days after stenting

  2. Death

    Death after stenting within the territory of target vessel.

    Time frame: 30 days after stenting

  3. Cerebrovascular events

    Ischemic or hemorrhagic stroke within the territory of the target vessel.

    Time frame: 30 days to1 year after stenting

  4. Death

    Vascular death after stenting within the territory of target vessel

    Time frame: 30 days to1 year after stenting

Secondary outcomes

  1. Complications

    During the peri-operative period, complications such as vasospasms, acute thrombosis, vascular rupture, cerebral infarction, and cerebral haemorrhage will be recorded.

    Time frame: Peri-operative period

  2. Number of participants with restenosis

    Magnetic resonance angiography (MRA) will be used to calculate the number and incidence of restenosis among all participants.

    Time frame: 1 year after stenting

  3. The degree of restenosis of the target vessel

    The degree of restenosis will be assessed by performing magnetic resonance angiography (MRA) using the Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) trial method for the measurements of arterial stenosis.

    Time frame: 1 year after stenting

  4. Change from baseline in The National Institutes of Health Stroke Scale (NIHSS) score

    The National Institutes of Health Stroke Scale (NIHSS) score is a tool used to objectively quantify the impairment caused by a stroke and to evaluate stroke severity. It ranges from 0 to 42, with 42 being the highest and 0 being the lowest. The higher the NIHSS score, the worse the neurological function.

    Time frame: Baseline and 30 days after stenting

  5. Change from baseline in modified Rankin Scale (mRS) score

    The modified Rankin Scale (mRS) score is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.it ranges from 0 to 6 .The higher the mRS score, the worse the prognosis.

    Time frame: Baseline and 30 days after stenting

  6. Change from baseline in The National Institutes of Health Stroke Scale (NIHSS) score

    The National Institutes of Health Stroke Scale (NIHSS) score is a tool used to objectively quantify the impairment caused by a stroke and to evaluate stroke severity. It ranges from 0 to 42, with 42 being the highest and 0 being the lowest. The higher the NIHSS score, the worse the neurological function.

    Time frame: Baseline and 1 year after stenting

  7. Change from baseline in modified Rankin Scale (mRS) score

    The modified Rankin Scale (mRS) score is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke.it ranges from 0 to 6 .The higher the mRS score, the worse the prognosis.

    Time frame: Baseline and 1 year after stenting

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Study locations

1 site
  • Ain shams university
    Cairo, Egypt
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05203887
Lead sponsor
Sohag University
Responsible party
Mostafa Abdelmomen Sayed (Assistant lecturer, Sohag University) — Principal investigator
First posted
Jan 24, 2022
Start date
Mar 1, 2022
Primary completion
Feb 15, 2024
Completion
Feb 20, 2024
Last update
Apr 18, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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