Prospective Cohort Registry Study on Multimodal Imaging Evaluation of Vulnerability of Intracranial and Extracranial Atherosclerotic Plaques: A Comparison of HR-VWI, OCT, and RWS
Sponsor study identifier
observational
561
1 country
1
Study Start
August 10, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 6, 2025
Actual (reported)August 10, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
August 21, 2025
Actual (reported)December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Diameter stenosis rate
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%
2024.8-2027.12
Identify different plaque components
2024.8-2027.12
OCT scanning scheme and image analysis
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.
Patients with moderate to severe stenosis (stenosis degree: 70% \~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study.
Patients with moderate to severe stenosis (stenosis degree: 70% \~ 99%) in both intracranial and extracranial arteries were considered for enrollment in this study.
Shanghai 6th People's Hospital
Shanghai, 200023, China
Yueqi Zhu, MD
Shanghai Jiao Tong University Affiliated Sixth People's Hospital
First Submitted
August 6, 2025
First Posted
August 21, 2025
Study Start
August 10, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2028
SeQuent ® Please CIS for the Treatment of INtracranial Atherosclerotic Stenosis
2024.8-2027.12
RWS
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.
2024.8-2027.12
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 30, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2025
Record last verified: 2025-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: