Flow Patterns and Stent Thrombosis
ConditionStent Thrombosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorQueen Mary University of London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent
Patients who have suffered thrombosis post-stent implantation
Disqualifiers
None
Trial population
A total of 120 patients who have undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 2 trial groupsGroup A: Stent thrombosis group
Group B: Control group
Trial outcomes
Primary outcomes
1
Haemodynamic shear stress and shear rate
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.
Time frame
1.5 yearsSecondary outcomes
1
OCT based stented segment reconstruction
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
Time frame
3 months2
Validation of the proposed reconstruction methodology
To validate in vivo and in-bench studies, the accuracy of the developed reconstruction method.
Time frame
4 months3
Development of automated frame work for reconstruction of stented segments
To design a user-friendly platform incorporating the new method to fast and accurately reconstruct vessels stented with different stent types.
Time frame
6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Queen Mary University of London
Lead sponsor
Barts Helth NHS Trust
Collaborator
Oxford University Hospitals NHS Trust
Collaborator
Royal Free Hospital NHS Foundation Trust
Collaborator
University Hospitals Bristol and Weston NHS Foundation Trust
Collaborator
Mid and South Essex NHS Foundation Trust
Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborator
Manchester University NHS Foundation Trust
Collaborator
King's College Hospital NHS Trust
Collaborator
San Giovanni Addolorata Hospital
Collaborator
Medstar Health Research Institute
Collaborator
Medical University of Warsaw
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
Hospital San Carlos, Madrid
Collaborator
The Leeds Teaching Hospitals NHS Trust
Collaborator
McMaster University Health Sciences Centre
Collaborator
Fujita Health University
Collaborator
Harbin Medical University
Collaborator
Yale University
Collaborator
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Collaborator
Erasmus Medical Center
Collaborator
Radbound University Medical Center
Collaborator
Department of Cardiovascular Surgery, German Heart Center Munich
Collaborator
Columbia University
Collaborator
The Queen Elizabeth Hospital
Collaborator
Yonsei University Hospital, Seoul, South Korea
Collaborator
Nara Medical University
Collaborator
Shinshu University School of Medicine
Collaborator
University Hospitals Sussex NHS Foundation Trust
Collaborator
Galeazzi Sant'Ambrogio Hospital - Milan
Collaborator
CORRIB Core Lab, University of Galway
Collaborator
Source ClinicalTrials.gov