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Starting soon Observational

Multimodal Imaging Evaluation of Vulnerability of Atherosclerotic Plaques: A Comparison of HR-VWI, OCT, and RWS

NCT07133451 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2025-08-10
Last updated
2025-08-21

Condition(s) studied

Intracranial Atherosclerotic Stenosis

Study summary

The primary objective of this study is to evaluate the vulnerability of intracranial and extracranial atherosclerotic plaques using HR-VWI, OCT, and RWS technologies, while exploring correlations among these three imaging techniques. Secondary objectives include: 1) Investigating the relationship between RWS and plaque progression and identifying optimal RWS predictors; 2) Further evaluating the clinical value of RWS and HR-VWI in stroke prediction through two-year clinical and HR-VWI follow-up evaluations.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * At least 18 years old; * Severe stenosis of intracranial arteries (stenosis degree: 70% \~ 99%, traditional angiography is required to confirm the degree of stenosis according to the criteria of Warfarin-Aspirin Symptomatic Intracranial Disease (WASID) study); * Carry out cerebral angiography and OCT within one week after HR-VWI examination; * The patient or the legal representative of the patient is able and willing to sign an informed consent form. Exclusion Criteria: * Non-atherosclerotic intracranial and extracranial artery stenosis, such as dissection, smoke disease, etc.; * There are contraindications to MRI, such as claustrophobia, metal implants, etc.; Renal insufficiency, elevated serum creatinine (more than twice the upper limit of normal); * Patients with severe cardiopulmonary diseases were considered unsuitable for this study; * Allergy to iodine or gadolinium contrast agent; * Participants who were unable to complete the study due to mental illness, cognitive or emotional disorder.

Primary outcome measure(s)

  • Diameter stenosis rate — 2024.8-2027.12
    According to the 3D TOF-MRA measurement of the lumen diameter at the narrowest part of the intracranial artery and the normal lumen diameter at the proximal end of the stenosis, the stenosis rate was calculated according to the WASID standard: diameter stenosis rate = \[1- (the diameter at the narrowest part / the normal diameter at the proximal end of the stenosis)\] × 100%
  • Identify different plaque components — 2024.8-2027.12
  • OCT scanning scheme and image analysis — 2024.8-2027.12
    This study utilized the ILUMIEN OPTIS system (Abbott Medical, USA) to obtain frequency-domain OCT (FD-OCT) images. The procedure was performed under general anesthesia. Patients first underwent DSA cerebral angiography, after which a 6F long sheath (Epsylar, Opti Med, USA) was placed proximal to the lesion. A distal access catheter was introduced near the target lesion, and under fluoroscopy guidance, a micro guidewire was advanced through the lesion into the normal arterial lumen distally. The Dragonfly OPTIS imaging catheter (Abbott Medical, USA) was then exchanged for standard "single-track" entry, guiding it into the target vascular lesion. A mixed solution of physiological saline and iohexol contrast agent (GE Healthcare, Cork, Ireland), with a 1:1 concentration, was injected via the distal access catheter. OCT images were captured using automated retraction technology during blood clearance.
  • RWS — 2024.8-2027.12
    Using single-position angiographic sequences, the cardiac cycle inference algorithm and automatic frame selection algorithm were applied to identify a key frame and multiple analysis frames with high image quality distributed across different phases of the same cardiac cycle. Subsequently, vascular segments of interest were defined on the key frame, and all corresponding matching segments were obtained through keypoint matching algorithms. The sub-pixel vascular contour segmentation algorithm was then used to generate detailed vessel outlines and calculate radial diameters for all analysis frames. Based on multi-frame vascular contours and diameter data, an automatic 2D point cloud registration algorithm was employed to determine radial alignment relationships between vascular segments. Finally, relative radial deformation was calculated using these alignment relationships and diameter information to derive RWS variation curves.

Trial sites (1)

FacilityCityRegionStatus
Shanghai 6th People's Hospital Shanghai China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07133451 on ClinicalTrials.gov ↗ ← All trials in China