Flow Patterns and Stent Thrombosis

Recruiting

• Conditions: Stent Thrombosis

• Registration Number: NCT06700018
• Lead Sponsor: Queen Mary University of London

Brief Summary

The goal of this observational study is to study the effect of haemodynamic forces on thrombus formation and identify haemodynamic markers that predict stent thrombosis events in patients who have undergone OCT-guided percutaneous coronary interventions.

The primary objective of the study is to examine the efficacy of blood flow patterns in predicting stent thrombosis. Researchers will compare the blood flow patterns of the stent thrombosis group with that of the control group to understand the influence of blood flow patterns on thrombus formation and progression.

Detailed Description

The incidences of Stent Thrombosis (ST) remain high in complex lesions and in high-risk patients. The use of intravascular imaging seems to be able to identify causes of ST, enabling prompt correction, and its use has been associated with better clinical outcomes in this setting. However, the efficacy of intravascular imaging features in predicting ST is limited. Computational fluid dynamic studies have shown that the local hemodynamic forces distribution has an effect on thrombus formation and can be responsible for the ST events. However, none of the studies today has explored in vivo the value of the flow disturbances in predicting events. The investigators have recently developed a method that is able to reconstruct vessel geometry accurately using coronary angiography and optical coherence tomography (OCT) data. Validation of this method in vitro and in human data showed promising results in accurately measuring shear stress and shear rate distribution.

This study, aims to explore the value of this method in predicting patients undergoing stent implantation with OCT imaging guidance that will suffer a ST. The investigators aim to collect data from 40 patients who had an ST after OCT-guided revascularization and from a control group of 80 patients who had no event after having stent implantation under OCT guidance. Investigators will further reconstruct the stented vessel from the OCT and the angiographic images, perform blood flow simulation and measure the shear rate and the shear stress in these two groups to explore the value of these metrics in predicting stent occlusion.

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-07
• Last Update Posted: 2025-03-11
• Primary Completion: 2025-09-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent
• Patients who have suffered thrombosis post-stent implantation

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Haemodynamic shear stress and shear rate	1.5 years	The haemodynamic shear rate and shear rate will be calculated by performing CFD simulations on reconstructed geometries obtained from the percutaneous coronary interventions of the patients. The efficacy of the haemodynamic shear stress and shear rate in predicting stent thrombosis will be studied.

Secondary Outcome Measures

Name	Time	Method
OCT based stented segment reconstruction	3 months	To develop a methodology for the reconstruction of stented segments from OCT and angiographic data that relies on the separate modelling of the lumen and stent architecture and fusion of these geometries in a final model
Validation of the proposed reconstruction methodology	4 months	To validate in vivo and in-bench studies, the accuracy of the developed reconstruction method.
Development of automated frame work for reconstruction of stented segments	6 months	To design a user-friendly platform incorporating the new method to fast and accurately reconstruct vessels stented with different stent types.

Trial Locations

Locations (1)

Queen Mary University of London; 🇬🇧 London, United Kingdom