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Completed

NCT Number: NCT05203887

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

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

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Key information

Conditions

Intracranial Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Arterial Diseases Intracranial Arteriosclerosis Nervous System Diseases Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain shams university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. Cerebrovascular events

    Time frame: 30 days after stenting

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

  2. Death

    Time frame: 30 days after stenting

    Death after stenting within the territory of target vessel.

  3. Cerebrovascular events

    Time frame: 30 days to1 year after stenting

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

  4. Death

    Time frame: 30 days to1 year after stenting

    Vascular death after stenting within the territory of target vessel

Secondary outcomes

  1. Complications

    Time frame: Peri-operative period

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

  2. Number of participants with restenosis

    Time frame: 1 year after stenting

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

  3. The degree of restenosis of the target vessel

    Time frame: 1 year after stenting

    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.

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

    Time frame: Baseline and 30 days after stenting

    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.

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

    Time frame: Baseline and 30 days after stenting

    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.

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

    Time frame: Baseline and 1 year after stenting

    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.

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

    Time frame: Baseline and 1 year after stenting

    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.

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 24, 2022
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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