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

NCT05203887 | Completed

• 1 other identifier: Soh-Med-22-01-10
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Intracranial Atherosclerosis

Outcome Measures

Primary Outcomes (4)

• Cerebrovascular events

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

  30 days after stenting

• Death

  Death after stenting within the territory of target vessel.

  30 days after stenting

• Cerebrovascular events

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

  30 days to1 year after stenting

• Death

  Vascular death after stenting within the territory of target vessel

  30 days to1 year after stenting

Secondary Outcomes (7)

• Complications

  Peri-operative period

• Number of participants with restenosis

  1 year after stenting

• The degree of restenosis of the target vessel

  1 year after stenting

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

  Baseline and 30 days after stenting

• Change from baseline in modified Rankin Scale (mRS) score

  Baseline and 30 days after stenting

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptomatic intracranial arterial stenosis caused by intracranial atherosclerosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Intracranial Arteriosclerosis

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: January 13, 2022
• First Posted: January 24, 2022
• Study Start: March 1, 2022
• Primary Completion: February 15, 2024
• Study Completion: February 20, 2024
• Last Updated: April 18, 2024

Record last verified: 2022-12

Locations

EG (1)