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

Intracranial Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05203887
• Other study ID #: Soh-Med-22-01-10
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: February 20, 2024

Study information

• Verified date: December 2022
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 20, 2024
• Est. primary completion date: February 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Intracranial Arteriosclerosis
• Intracranial Atherosclerosis

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebrovascular events	Any stroke (including ischemic or hemorrhagic stroke) or TIA after stenting within the territory of the target vessel.	30 days after stenting
Primary	Death	Death after stenting within the territory of target vessel.	30 days after stenting
Primary	Cerebrovascular events	Ischemic or hemorrhagic stroke within the territory of the target vessel.	30 days to1 year after stenting
Primary	Death	Vascular death after stenting within the territory of target vessel	30 days to1 year after stenting
Secondary	Complications	During the peri-operative period, complications such as vasospasms, acute thrombosis, vascular rupture, cerebral infarction, and cerebral haemorrhage will be recorded.	Peri-operative period
Secondary	Number of participants with restenosis	Magnetic resonance angiography (MRA) will be used to calculate the number and incidence of restenosis among all participants.	1 year after stenting
Secondary	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.	1 year after stenting
Secondary	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.	Baseline and 30 days after stenting
Secondary	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.	Baseline and 30 days after stenting
Secondary	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.	Baseline and 1 year after stenting
Secondary	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.	Baseline and 1 year after stenting