Calcification is a risk factor for intracranial in-stent restenosis: an optical coherence tomography study.
Tianhua Li, Ran Xu, Yan Ma...
https://pubmed.ncbi.nlm.nih.gov/37536931Actively Recruiting
Age: 18Years +
All Genders
ID05550077
Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis: a Prospective Registry Study (OCT-ICAS)
Led by jiaoliqun · Updated on 2022-09-23
400
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical significance of optical coherence tomography (OCT) in treating intracranial atherosclerotic stenosis (ICAS), a condition linked to ischemic stroke. ICAS accounts for a significant portion of stroke cases, especially in Asia, and understanding the characteristics of atheromatous plaques may help predict stroke risk and guide treatment. This study aims to improve insight into how OCT can evaluate vessel wall structure to better guide interventional therapy and correlate plaque features with clinical and biological information. Participants will undergo OCT and classical imaging evaluations like Transcranial Color Doppler (TCCD) and high-resolution MRI. Based on OCT findings, tailored treatments such as antithrombotic management or post-dilation may be applied if specific plaque characteristics are observed. Another group will receive standard imaging followed by percutaneous transluminal angioplasty and stenting without OCT guidance. Throughout the study, researchers will monitor participants for safety outcomes including death or stroke within 30 days of enrollment. Longer-term outcomes such as death, stroke recurrence, restenosis, and dependency will be assessed at one year. Medical imaging, clinical evaluations, and biological data will be collected to understand treatment effects and plaque characteristics during the study period ending in 2027.
CONDITIONS
Brief Title
Optical Coherence Tomography for Intracranial Atherosclerotic Stenosis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Symptomatic intracranial atherosclerotic stenosis (ICAS) with transient ischemic attack or stroke related to the stenotic artery
- Stenosis degree of 50% or greater measured by digital subtraction angiography
- Stenosis located in at least one major intracranial artery (internal carotid, vertebral, middle cerebral, or basilar artery)
- Adults aged 18 years or older
You will not qualify if you...
- Presence of arteriovenous malformation
- Presence of aneurysm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 week
Participants undergo imaging evaluations including Optical Coherence Tomography (OCT) or classical imaging techniques to assess intracranial atherosclerotic stenosis and plaque characteristics.
1 to 2 visits depending on imaging assessments
Treatment
Duration - Single day procedure with immediate post-treatment period
Participants receive percutaneous transluminal angioplasty and stenting, with or without tailored management guided by OCT findings.
1 procedure visit
Long-term Monitoring
Duration - 1 year
Participants are followed for safety and efficacy outcomes including stroke, restenosis, and dependency for up to 1 year after enrollment.
Periodic follow-up visits over 1 year
Trial Site Locations
Total: 1 location
1
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
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Research Team
L
Liqun Jiao, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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