Clinical trial NCT05203887: Short- and Long-term Outcomes of Stenting for Symptomatic Intracranial Arterial Stenosis: a Cohort Study
Official title: Short- and Long-term Outcomes of Stenting for Symptomatic Intracranial Arterial Stenosis: a Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Atherosclerosis
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic intracranial arterial stenosis caused by intracranial atherosclerosis

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


Eligibility criteria: 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.

Primary outcomes:
measure: Cerebrovascular events
timeFrame: 30 days after stenting
measure: Death
timeFrame: 30 days after stenting
measure: Cerebrovascular events
timeFrame: 30 days to1 year after stenting
measure: Death
timeFrame: 30 days to1 year after stenting
Secondary outcomes:
measure: Complications
timeFrame: Peri-operative period
measure: Number of participants with restenosis
timeFrame: 1 year after stenting
measure: The degree of restenosis of the target vessel
timeFrame: 1 year after stenting
measure: Change from baseline in The National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: Baseline and 30 days after stenting
measure: Change from baseline in modified Rankin Scale (mRS) score
timeFrame: Baseline and 30 days after stenting
measure: Change from baseline in The National Institutes of Health Stroke Scale (NIHSS) score
timeFrame: Baseline and 1 year after stenting
measure: Change from baseline in modified Rankin Scale (mRS) score
timeFrame: Baseline and 1 year after stenting
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
References: