Intracranial AtherosclerosisNCT05203887
Short- and Long-term Outcomes of Stenting for Symptomatic Intracranial Arterial Stenosis: a Cohort Study
An observational study of Intracranial Atherosclerosis, run by Sohag University at 1 site in Egypt.
Trial summary
The purpose of this study is to assess short and long term outcomes of stenting for symptomatic intracranial arterial stenosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Intracranial Atherosclerosis
- How many people
- 43 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2022to 20 Feb 2024
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic intracranial arterial stenosis caused by intracranial atherosclerosis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess short and long term outcomes of stenting for symptomatic intracranial arterial stenosis.
- Conditions
- Intracranial Atherosclerosis
- Medical subject headings
- Intracranial Arteriosclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebrovascular events
Any stroke (including ischemic or hemorrhagic stroke) or TIA after stenting within the territory of the target vessel.
Measured: 30 days after stenting
Death
Death after stenting within the territory of target vessel.
Measured: 30 days after stenting
Cerebrovascular events
Ischemic or hemorrhagic stroke within the territory of the target vessel.
Measured: 30 days to1 year after stenting
Death
Vascular death after stenting within the territory of target vessel
Measured: 30 days to1 year after stenting
Secondary outcomes (7)
Complications
During the peri-operative period, complications such as vasospasms, acute thrombosis, vascular rupture, cerebral infarction, and cerebral haemorrhage will be recorded.
Measured: Peri-operative period
Number of participants with restenosis
Magnetic resonance angiography (MRA) will be used to calculate the number and incidence of restenosis among all participants.
Measured: 1 year after stenting
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.
Measured: 1 year after stenting
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.
Measured: Baseline and 30 days after stenting
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.
Measured: Baseline and 30 days after stenting
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.
Measured: Baseline and 1 year after stenting
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.
Measured: Baseline and 1 year after stenting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Mar 2022
- Primary completion15 Feb 2024
- Study completion20 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Abdelmomen Sayed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05203887
- Sponsor's protocol ID
- Soh-Med-22-01-10
- Status last verified
- Dec 2022
- First submitted
- 13 Jan 2022
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short- and Long-term Outcomes of Stenting for Symptomatic Intracranial Arterial Stenosis: a Cohort Study
- ClinicalTrials.gov ID
- NCT05203887
- Acronym / sponsor ID
- Soh-Med-22-01-10
- Conditions
- Intracranial Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 15 Feb 2024 (actual)
- Study completion
- 20 Feb 2024 (actual)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess short and long term outcomes of stenting for symptomatic intracranial arterial stenosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic intracranial arterial stenosis caused by intracranial atherosclerosis
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Death
Time frame: 30 days after stenting
Death after stenting within the territory of target vessel.
Cerebrovascular events
Time frame: 30 days to1 year after stenting
Ischemic or hemorrhagic stroke within the territory of the target vessel.
Death
Time frame: 30 days to1 year after stenting
Vascular death after stenting within the territory of target vessel
7 secondary outcomes
Complications
Time frame: Peri-operative period
Number of participants with restenosis
Time frame: 1 year after stenting
The degree of restenosis of the target vessel
Time frame: 1 year after stenting
Change from baseline in The National Institutes of Health Stroke Scale (NIHSS) score
Time frame: Baseline and 30 days after stenting
Change from baseline in modified Rankin Scale (mRS) score
Time frame: Baseline and 30 days after stenting
Change from baseline in The National Institutes of Health Stroke Scale (NIHSS) score
Time frame: Baseline and 1 year after stenting
Change from baseline in modified Rankin Scale (mRS) score
Time frame: Baseline and 1 year after stenting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Atherosclerosis, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebrovascular events (time frame: 30 days after stenting). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.