Flow Patterns and Stent Thrombosis

NCT06700018 | Recruiting

• 1 other identifier: 331221
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stent Thrombosis

Keywords

stent thrombosis; endothelial shear stress; optical coherence tomography; blood flow simulations

Outcome Measures

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.

  1.5 years

Secondary Outcomes (3)

• OCT based stented segment reconstruction

  3 months

• Validation of the proposed reconstruction methodology

  4 months

• Development of automated frame work for reconstruction of stented segments

  6 months

Study Arms (2)

Stent thrombosis group

40 patients who have suffered cardiovascular events attributed to stent thrombosis within one year of post-stent implementation will be recruited.

Control group

80 patients not having suffered stent thrombosis but will have uneventful follow-up. An effort will be made so that these patients have similar clinical presentation, baseline demographics and angiographic results post PCI and receive treatment with a similar antiplatelet regime compared to those who suffered stent thrombosis.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 120 patients who have undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent

You may qualify if:

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

Sponsors & Collaborators

• Barts Helth NHS Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• Royal Free Hospital NHS Foundation Trust: collaborator
• Mid and South Essex NHS Foundation Trust: collaborator
• Newcastle-upon-Tyne Hospitals NHS 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
• Queen Mary University of London: lead
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator
• Liverpool Heart and Chest Hospital NHS Foundation Trust: collaborator

Study Sites (1)

Queen Mary University of London

London, United Kingdom

RECRUITING

Related Publications (13)

• Gijsen F, Katagiri Y, Barlis P, Bourantas C, Collet C, Coskun U, Daemen J, Dijkstra J, Edelman E, Evans P, van der Heiden K, Hose R, Koo BK, Krams R, Marsden A, Migliavacca F, Onuma Y, Ooi A, Poon E, Samady H, Stone P, Takahashi K, Tang D, Thondapu V, Tenekecioglu E, Timmins L, Torii R, Wentzel J, Serruys P. Expert recommendations on the assessment of wall shear stress in human coronary arteries: existing methodologies, technical considerations, and clinical applications. Eur Heart J. 2019 Nov 1;40(41):3421-3433. doi: 10.1093/eurheartj/ehz551. No abstract available.

  PMID: 31566246 BACKGROUND

• Li Y, Li Z, Holck EN, Xu B, Karanasos A, Fei Z, Chang Y, Chu M, Dijkstra J, Christiansen EH, Reiber JHC, Holm NR, Tu S. Local Flow Patterns After Implantation of Bioresorbable Vascular Scaffold in Coronary Bifurcations - Novel Findings by Computational Fluid Dynamics. Circ J. 2018 May 25;82(6):1575-1583. doi: 10.1253/circj.CJ-17-1332. Epub 2018 Mar 24.

  PMID: 29576586 BACKGROUND

• O'Brien CC, Kolandaivelu K, Brown J, Lopes AC, Kunio M, Kolachalama VB, Edelman ER. Constraining OCT with Knowledge of Device Design Enables High Accuracy Hemodynamic Assessment of Endovascular Implants. PLoS One. 2016 Feb 23;11(2):e0149178. doi: 10.1371/journal.pone.0149178. eCollection 2016.

  PMID: 26906566 BACKGROUND

• Migliori S, Chiastra C, Bologna M, Montin E, Dubini G, Aurigemma C, Fedele R, Burzotta F, Mainardi L, Migliavacca F. A framework for computational fluid dynamic analyses of patient-specific stented coronary arteries from optical coherence tomography images. Med Eng Phys. 2017 Sep;47:105-116. doi: 10.1016/j.medengphy.2017.06.027. Epub 2017 Jul 12.

  PMID: 28711588 BACKGROUND

• Li Y, Gutierrez-Chico JL, Holm NR, Yang W, Hebsgaard L, Christiansen EH, Maeng M, Lassen JF, Yan F, Reiber JH, Tu S. 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. J Am Coll Cardiol. 2015 Jul 14;66(2):125-35. doi: 10.1016/j.jacc.2015.05.008.

  PMID: 26160628 BACKGROUND

• Torii R, Stettler R, Raber L, Zhang YJ, Karanasos A, Dijkstra J, Patel K, Crake T, Hamshere S, Garcia-Garcia HM, Tenekecioglu E, Ozkor M, Baumbach A, Windecker S, Serruys PW, Regar E, Mathur A, Bourantas CV. Implications of the local hemodynamic forces on the formation and destabilization of neoatherosclerotic lesions. Int J Cardiol. 2018 Dec 1;272:7-12. doi: 10.1016/j.ijcard.2018.06.065. Epub 2018 Jun 19.

  PMID: 30293579 BACKGROUND

• Tenekecioglu E, Torii R, Sotomi Y, Collet C, Dijkstra J, Miyazaki Y, Crake T, Su S, Costa R, Chamie D, Liew HB, Santoso T, Onuma Y, Abizaid A, Bourantas CV, Serruys PW. The Effect of Strut Protrusion on Shear Stress Distribution: Hemodynamic Insights From a Prospective Clinical Trial. JACC Cardiovasc Interv. 2017 Sep 11;10(17):1803-1805. doi: 10.1016/j.jcin.2017.06.020. No abstract available.

  PMID: 28882287 BACKGROUND

• Torii R, Tenekecioglu E, Katagiri Y, Chichareon P, Sotomi Y, Dijkstra J, Asano T, Modolo R, Takahashi K, Jonker H, van Geuns R, Onuma Y, Pekkan K, Bourantas CV, Serruys PW. The impact of plaque type on strut embedment/protrusion and shear stress distribution in bioresorbable scaffold. Eur Heart J Cardiovasc Imaging. 2020 Apr 1;21(4):454-462. doi: 10.1093/ehjci/jez155.

  PMID: 31215995 BACKGROUND

• Papafaklis MI, Bourantas CV, Yonetsu T, Vergallo R, Kotsia A, Nakatani S, Lakkas LS, Athanasiou LS, Naka KK, Fotiadis DI, Feldman CL, Stone PH, Serruys PW, Jang IK, Michalis LK. 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. EuroIntervention. 2015 Aug;11(4):407-15. doi: 10.4244/EIJY14M06_11.

  PMID: 24974809 BACKGROUND

• Papafaklis MI, Bourantas CV, Farooq V, Diletti R, Muramatsu T, Zhang Y, Fotiadis DI, Onuma Y, Garcia Garcia HM, Michalis LK, Serruys PW. 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. EuroIntervention. 2013 Nov;9(7):890. doi: 10.4244/EIJV9I7A147. No abstract available.

  PMID: 23856322 BACKGROUND

• Bourantas CV, Papafaklis MI, Lakkas L, Sakellarios A, Onuma Y, Zhang YJ, Muramatsu T, Diletti R, Bizopoulos P, Kalatzis F, Naka KK, Fotiadis DI, Wang J, Garcia Garcia HM, Kimura T, Michalis LK, Serruys PW. Fusion of optical coherence tomographic and angiographic data for more accurate evaluation of the endothelial shear stress patterns and neointimal distribution after bioresorbable scaffold implantation: comparison with intravascular ultrasound-derived reconstructions. Int J Cardiovasc Imaging. 2014 Mar;30(3):485-94. doi: 10.1007/s10554-014-0374-3. Epub 2014 Jan 24.

  PMID: 24458955 BACKGROUND

• Stone PH, Saito S, Takahashi S, Makita Y, Nakamura S, Kawasaki T, Takahashi A, Katsuki T, Nakamura S, Namiki A, Hirohata A, Matsumura T, Yamazaki S, Yokoi H, Tanaka S, Otsuji S, Yoshimachi F, Honye J, Harwood D, Reitman M, Coskun AU, Papafaklis MI, Feldman CL; PREDICTION Investigators. Prediction of progression of coronary artery disease and clinical outcomes using vascular profiling of endothelial shear stress and arterial plaque characteristics: the PREDICTION Study. Circulation. 2012 Jul 10;126(2):172-81. doi: 10.1161/CIRCULATIONAHA.112.096438. Epub 2012 Jun 21.

  PMID: 22723305 BACKGROUND

• Thondapu V, Bourantas CV, Foin N, Jang IK, Serruys PW, Barlis P. Biomechanical stress in coronary atherosclerosis: emerging insights from computational modelling. Eur Heart J. 2017 Jan 7;38(2):81-92. doi: 10.1093/eurheartj/ehv689.

  PMID: 28158723 BACKGROUND

Central Study Contacts

Christos Bourantas

CONTACT

+442073777000; c.bourantas@qmul.ac.uk

Andreas Baumbach

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: November 21, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): July 14, 2026
• Study Completion (Estimated): July 14, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Locations

GB (1)