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

Completed

• Conditions: Intracranial Atherosclerosis

• Registration Number: NCT05203887
• Lead Sponsor: Sohag University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-13
• Study First Submitted QC: 2022-01-13
• Study First Posted: 2022-01-24
• Study Start: 2022-03-01
• Status Verified: 2022-12
• Primary Completion: 2024-02-15
• Study Completion: 2024-02-20
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cerebrovascular events	30 days to1 year after stenting	Ischemic or hemorrhagic stroke within the territory of the target vessel.
Death	30 days to1 year after stenting	Vascular death after stenting within the territory of target vessel

Secondary Outcome Measures

Name	Time	Method
Number of participants with restenosis	1 year after stenting	Magnetic resonance angiography (MRA) will be used to calculate the number and incidence of restenosis among all participants.
Complications	Peri-operative period	During the peri-operative period, complications such as vasospasms, acute thrombosis, vascular rupture, cerebral infarction, and cerebral haemorrhage will be recorded.
Change from baseline in The National Institutes of Health Stroke Scale (NIHSS) score	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.
The degree of restenosis of the target vessel	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.
Change from baseline in modified Rankin Scale (mRS) score	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.

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt