Actively Recruiting

All Genders
ID06700018

Development of a Novel Method to Evaluate Blood Flow Patterns in Stented Arteries and Their Role in Stent Thrombosis

Led by Queen Mary University of London · Updated on 2026-02-27

120

Participants Needed

1

Research Sites

N/A

Total Duration

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Sponsors

Q

Queen Mary University of London

Lead Sponsor

B

Barts Helth NHS Trust

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating how blood flow patterns affect clot formation in patients who have received OCT-guided percutaneous coronary interventions with stent implantation. The study aims to identify blood flow markers that can predict stent thrombosis, a serious complication where a blood clot forms within a stent. This observational study compares patients who experienced stent thrombosis with those who did not, to better understand the role of blood flow in clot development. The study involves collecting data from two groups: 40 patients who had stent thrombosis and 80 patients without this event after stent placement. Using coronary angiography and optical coherence tomography (OCT) images, researchers will reconstruct the stented vessel geometry and simulate blood flow to measure shear stress and shear rate. These measurements will help evaluate whether these blood flow factors can predict stent thrombosis. Participants will have their stented vessel segments reconstructed and analyzed over several months. The study will assess the accuracy of the reconstruction method and develop automated tools for this process. Researchers will monitor blood flow forces for up to 1.5 years to see how they relate to clot formation. This detailed evaluation aims to improve understanding of stent thrombosis and possibly guide future treatments.

CONDITIONS

Brief Title

Flow Patterns and Stent Thrombosis

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients who have undergone OCT-guided percutaneous coronary intervention and had a second-generation drug-eluting stent implanted
  • Patients who have experienced thrombosis after stent implantation
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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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 6 months

Participants undergo OCT-guided percutaneous coronary intervention and imaging to reconstruct stented vessel segments and collect data for flow simulation analysis.

1 to 3 visits depending on imaging and reconstruction procedures

Long-term Monitoring

Duration - Up to 1.5 years

Participants are observed over time to assess haemodynamic shear stress and shear rate and monitor for stent thrombosis events.

Periodic follow-up visits during observation period

Trial Site Locations

Total: 1 location

1

Queen Mary University of London

London, United Kingdom

Actively Recruiting

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Research Team

C

Christos Bourantas

A

Andreas Baumbach

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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Published Research Related To This Trial

Expert recommendations on the assessment of wall shear stress in human coronary arteries: existing methodologies, technical considerations, and clinical applications.

Frank Gijsen, Yuki Katagiri, Peter Barlis...

https://pubmed.ncbi.nlm.nih.gov/31566246

Local Flow Patterns After Implantation of Bioresorbable Vascular Scaffold in Coronary Bifurcations - Novel Findings by Computational Fluid Dynamics.

Yingguang Li, Zehang Li, Emil N Holck...

https://pubmed.ncbi.nlm.nih.gov/29576586

Constraining OCT with Knowledge of Device Design Enables High Accuracy Hemodynamic Assessment of Endovascular Implants.

Caroline C O'Brien, Kumaran Kolandaivelu, Jonathan Brown...

https://pubmed.ncbi.nlm.nih.gov/26906566

A framework for computational fluid dynamic analyses of patient-specific stented coronary arteries from optical coherence tomography images.

Susanna Migliori, Claudio Chiastra, Marco Bologna...

https://pubmed.ncbi.nlm.nih.gov/28711588

Impact of Side Branch Modeling on Computation of Endothelial Shear Stress in Coronary Artery Disease: Coronary Tree Reconstruction by Fusion of 3D Angiography and OCT.

Yingguang Li, Juan Luis Gutiérrez-Chico, Niels R Holm...

https://pubmed.ncbi.nlm.nih.gov/26160628

The Effect of Strut Protrusion on Shear Stress Distribution: Hemodynamic Insights From a Prospective Clinical Trial.

Erhan Tenekecioglu, Ryo Torii, Yohei Sotomi...

https://pubmed.ncbi.nlm.nih.gov/28882287

Anatomically correct three-dimensional coronary artery reconstruction using frequency domain optical coherence tomographic and angiographic data: head-to-head comparison with intravascular ultrasound for endothelial shear stress assessment in humans.

Michail I Papafaklis, Christos V Bourantas, Taishi Yonetsu...

https://pubmed.ncbi.nlm.nih.gov/24974809

In vivo assessment of the three-dimensional haemodynamic micro-environment following drug-eluting bioresorbable vascular scaffold implantation in a human coronary artery: fusion of frequency domain optical coherence tomography and angiography.

Michail I Papafaklis, Christos V Bourantas, Vasim Farooq...

https://pubmed.ncbi.nlm.nih.gov/23856322