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NCT Number: NCT06700018

Flow Patterns and Stent Thrombosis

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.

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

Queen Mary University of London

London, United Kingdom

Location status: Recruiting

Location contact

Andreas Baumbach

SUB_INVESTIGATOR

Christos Bourantas

CONTACT

[email protected]

+442073777000

Christos Bourantas

PRINCIPAL_INVESTIGATOR

Ryo Torri

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Primary outcomes

  1. Haemodynamic shear stress and shear rate

    Time frame: 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 outcomes

  1. OCT based stented segment reconstruction

    Time frame: 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

  2. Validation of the proposed reconstruction methodology

    Time frame: 4 months

    To validate in vivo and in-bench studies, the accuracy of the developed reconstruction method.

  3. Development of automated frame work for reconstruction of stented segments

    Time frame: 6 months

    To design a user-friendly platform incorporating the new method to fast and accurately reconstruct vessels stented with different stent types.

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Baumbach

CONTACT

Christos Bourantas

CONTACT

[email protected]

+442073777000

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • Barts & The London NHS Trust
  • CORRIB Core Lab, University of Galway
  • Columbia University
  • Department of Cardiovascular Surgery, German Heart Center Munich
  • Erasmus Medical Center
  • Fujita Health University
  • Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
  • Galeazzi Sant'Ambrogio Hospital - Milan
  • Harbin Medical University
  • Hospital San Carlos, Madrid
  • Insel Gruppe AG, University Hospital Bern
  • King's College Hospital NHS Trust
  • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • Manchester University NHS Foundation Trust
  • McMaster University Health Sciences Centre
  • Medical University of Warsaw
  • Medstar Health Research Institute
  • Mid and South Essex NHS Foundation Trust
  • Nara Medical University
  • Newcastle-upon-Tyne Hospitals NHS Trust
  • Oxford University Hospitals NHS Trust
  • Radbound University Medical Center
  • Royal Free Hospital NHS Foundation Trust
  • San Giovanni Addolorata Hospital
  • Shinshu University School of Medicine
  • The Leeds Teaching Hospitals NHS Trust
  • The Queen Elizabeth Hospital
  • University Hospitals Bristol and Weston NHS Foundation Trust
  • University Hospitals Sussex NHS Foundation Trust
  • Yale University
  • Yonsei University Hospital, Seoul, South Korea

Registry information

Official study title

Development of a Novel Method for Detailed Evaluation of Blood Flow Patterns in Stented Segments and Assessment of Their Role in Stent Thrombosis

Acronym: TISIS registry

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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