Intracranial AtherosclerosisOCT-ICASNCT05550077
Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis
An observational study of Intracranial Atherosclerosis and Optical Coherence Tomography, run by jiaoliqun at 1 site in China.
Trial summary
To evaluate the clinical significance of optical coherence tomography (OCT) in interventional treatment of intracranial atherosclerotic stenosis (ICAS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Atherosclerosis, Optical Coherence Tomography, Plaque, Atherosclerotic
- What is being tested?
- Optical Coherence Tomography and Percutaneous transluminal angioplasty and stenting
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2020to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults (aged over 18) with symptomatic ICAS (≥ 50%) will be enrolled.
Who may be able to join
- Symptomatic ICAS. Participants with ICAS with a transient ischaemic attack (TIA) or stroke attributable to the territory of the stenotic artery were defined as symptomatic. A TIA was defined as a transient episode of neurological dysfunction (focal weakness or language disturbance, transient monocular blindness, or required assistance in walking) caused by focal brain or retinal ischaemia that lasted for at least 10 minutes but resolved within 24 hours
- Stenotic degree ≥ 50%, measured by digital subtraction angiography
- The stenosis must located in at least one major intracranial artery (internal carotid artery, vertebral artery, middle cerebral artery, or basilar artery)
Who cannot join
- Arteriovenous Malformation
- Aneurysm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100005
Ran Xu, MD, +8615001376121, xrqssq@126.com
About this study
Official title: Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis: a Prospective Registry Study (OCT-ICAS)
To evaluate the clinical significance of optical coherence tomography (OCT) in interventional treatment of intracranial atherosclerotic stenosis (ICAS).
Read the detailed description
Stroke was the second leading cause of death worldwide and the leading cause of death in China in 2017. ICAS accounted for 10% to 15% of ischemic stroke in Western countries, and as much as 46.6%in Asia in 2009.
For patients with ICAS, the risk of stroke is highly related to the histopathology of atheromatous plaques. Therefore, characterizing the morphology and composition of plaques in ICAS may help to predict the risk of stroke occurrence and allow the adoption of preventive or therapeutic management to prevent such life-threatening events. OCT, with a resolution of 10μm, may provide more reliable information in characterizing atheromatous plagues.
This study aims to get a better insight into the value of OCT in evaluating the vessel wall structure and therefore guiding the interventional therapy of ICAS. In addition, the clinical and biological information will be included to achieve correlation analysis so as to get biomarkers subject to various plaque characteristics.
- Conditions
- Intracranial Atherosclerosis, Optical Coherence Tomography, Plaque, Atherosclerotic, Artery Stenosis, Ischemic Stroke
- Being tested
- Optical Coherence Tomography, Percutaneous transluminal angioplasty and stenting
- Keywords
- Optical Coherence Tomography, Intravascular Imaging, Intracranial Atherosclerotic Stenosis, Percutaneous Transluminal Angioplasty and Stenting
- Medical subject headings
- Intracranial Arteriosclerosis, Plaque, Atherosclerotic, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDiagnostic test
Intravascular evaluation for vessel wall structure of intracranial atherosclerotic stenosis by application of optical coherence tomography
Percutaneous transluminal angioplasty and stentingProcedure or surgery
Percutaneous transluminal angioplasty and stenting will be performed follow the standard or adjusted according to OCT evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Optical Coherence Tomography (OCT) | OCT and other classical imaging evaluation such as Transcranial Color Doppler (TCCD) and High resolution-MRI will be performed. The tailored treatment (such as anti-thrombotic management, post-dilation, et al) will be considered when specific plaque characteristics (including but not limited to in situ thrombus formation, macrocacilfication, et al), were observed under OCT. Receives: Diagnostic Test: Optical Coherence Tomography; Procedure: Percutaneous transluminal angioplasty and stenting | |
| Non-Optical Coherence Tomography (N-OCT) | Classical imaging evaluation such as TCCD and High resolution-MRI will be performed, followed by standard percutaneous transluminal angioplasty and stenting. Receives: Procedure: Percutaneous transluminal angioplasty and stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcomes: short-term death or stroke
We defined 'short-term' as the periprocedural period, or mean follow-up time less than or equal to three months after enrollment. Stroke was identified in the vascular territory of the stenosed vessel, either ischaemic or haemorrhagic. We defined death or stroke as a composite of death of any cause or non-fatal stroke of any type in any territory.
Measured: 30 days after enrollment
Secondary outcomes (6)
Death or stroke
(long term; more than three months)
Measured: 1 year after enrollment
Ipsilateral stroke
(same territory as the index stenosis)
Measured: 1 year after enrollment
Type of recurrent event
(TIA, ischaemic stroke, haemorrhagic stroke)
Measured: 1 year after enrollment
Death
(long term; more than three months)
Measured: 1 year after enrollment
Restenosis
(≥ 50%) of the involved vessel documented by conventional cerebral angiography
Measured: 1 year after enrollment
Dependency
Modified Rankin Scale or equivalent
Measured: 1 year after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2022
- Study start15 Mar 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AtherosclerosisStudies of the same condition, open and under way.
- 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
- 400 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- jiaoliqun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, jiaoliqun, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05550077
- Sponsor's protocol ID
- OCT-ICAS
- Acronym
- OCT-ICAS
- Status last verified
- Sep 2022
- First submitted
- 18 Sep 2022
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li T, Xu R, Ma Y, Wang T, Yang B, Jiao L. Calcification is a risk factor for intracranial in-stent restenosis: an optical coherence tomography study. J Neurointerv Surg. 2024 Aug 14;16(9):897-901. doi: 10.1136/jnis-2023-020624.
PubMed 37536931
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis: a Prospective Registry Study (OCT-ICAS)
- ClinicalTrials.gov ID
- NCT05550077
- Acronym / sponsor ID
- OCT-ICAS / OCT-ICAS
- Conditions
- Intracranial Atherosclerosis, Optical Coherence Tomography, Plaque, Atherosclerotic, Artery Stenosis, Ischemic Stroke
- Keywords
- Optical Coherence Tomography, Intravascular Imaging, Intracranial Atherosclerotic Stenosis, Percutaneous Transluminal Angioplasty and Stenting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- jiaoliqunUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Sep 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.
To evaluate the clinical significance of optical coherence tomography (OCT) in interventional treatment of intracranial atherosclerotic stenosis (ICAS).
Detailed description
Stroke was the second leading cause of death worldwide and the leading cause of death in China in 2017. ICAS accounted for 10% to 15% of ischemic stroke in Western countries, and as much as 46.6%in Asia in 2009.
For patients with ICAS, the risk of stroke is highly related to the histopathology of atheromatous plaques. Therefore, characterizing the morphology and composition of plaques in ICAS may help to predict the risk of stroke occurrence and allow the adoption of preventive or therapeutic management to prevent such life-threatening events. OCT, with a resolution of 10μm, may provide more reliable information in characterizing atheromatous plagues.
This study aims to get a better insight into the value of OCT in evaluating the vessel wall structure and therefore guiding the interventional therapy of ICAS. In addition, the clinical and biological information will be included to achieve correlation analysis so as to get biomarkers subject to various plaque characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optical Coherence Tomography (OCT) | – | Diagnostic Test: Optical Coherence Tomography, Procedure: Percutaneous transluminal angioplasty and stentingOCT and other classical imaging evaluation such as Transcranial Color Doppler (TCCD) and High resolution-MRI will be performed. The tailored treatment (such as anti-thrombotic management, post-dilation, et al) will be considered when specific plaque characteristics (including but not limited to in situ thrombus formation, macrocacilfication, et al), were observed under OCT. |
| Non-Optical Coherence Tomography (N-OCT) | – | Procedure: Percutaneous transluminal angioplasty and stentingClassical imaging evaluation such as TCCD and High resolution-MRI will be performed, followed by standard percutaneous transluminal angioplasty and stenting. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (aged over 18) with symptomatic ICAS (≥ 50%) will be enrolled.
Key inclusion criteria (3 listed)
- Symptomatic ICAS. Participants with ICAS with a transient ischaemic attack (TIA) or stroke attributable to the territory of the stenotic artery were defined as symptomatic. A TIA was defined as a transient episode of neurological dysfunction (focal weakness or language disturbance, transient monocular blindness, or required assistance in walking) caused by focal brain or retinal ischaemia that lasted for at least 10 minutes but resolved within 24 hours
- Stenotic degree ≥ 50%, measured by digital subtraction angiography
- The stenosis must located in at least one major intracranial artery (internal carotid artery, vertebral artery, middle cerebral artery, or basilar artery)
Key exclusion criteria (2 listed)
- Arteriovenous Malformation
- Aneurysm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence TomographyIntravascular evaluation for vessel wall structure of intracranial atherosclerotic stenosis by application of optical coherence tomography | Diagnostic test | Optical Coherence Tomography (OCT) |
| Percutaneous transluminal angioplasty and stentingPercutaneous transluminal angioplasty and stenting will be performed follow the standard or adjusted according to OCT evaluation. | Procedure or surgery | Non-Optical Coherence Tomography (N-OCT), Optical Coherence Tomography (OCT) |
Primary outcome
Safety outcomes: short-term death or stroke
Time frame: 30 days after enrollment
We defined 'short-term' as the periprocedural period, or mean follow-up time less than or equal to three months after enrollment. Stroke was identified in the vascular territory of the stenosed vessel, either ischaemic or haemorrhagic. We defined death or stroke as a composite of death of any cause or non-fatal stroke of any type in any territory.
6 secondary outcomes
Death or stroke
Time frame: 1 year after enrollment
Ipsilateral stroke
Time frame: 1 year after enrollment
Type of recurrent event
Time frame: 1 year after enrollment
Death
Time frame: 1 year after enrollment
Restenosis
Time frame: 1 year after enrollment
Dependency
Time frame: 1 year after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Derived from this study: PubMed 37536931Li T, Xu R, Ma Y, Wang T, Yang B, Jiao L. Calcification is a risk factor for intracranial in-stent restenosis: an optical coherence tomography study. J Neurointerv Surg. 2024 Aug 14;16(9):897-901. doi: 10.1136/jnis-2023-020624.
- Individual participant dataSharing planned: Undecided
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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.
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 and Optical Coherence Tomography, run by jiaoliqun at 1 site in China.
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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Sep 2022. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liqun Jiao, Professor (+8613911224991, liqunjiao@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcomes: short-term death or stroke (time frame: 30 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05550077, which also lists 1 linked publication.
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 23 Sep 2022.