Flow Patterns and Stent Thrombosis

NCT ID: NCT06700018

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-03-31

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.

Conditions

Stent Thrombosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Stent thrombosis group

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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Barts Helth NHS Trust

UNKNOWN

Sponsor Role: collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Royal Free Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Mid and South Essex NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Newcastle-upon-Tyne Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

Liverpool Heart and Chest Hospital NHS Foundation Trust

OTHER

Sponsor Role: collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role: collaborator

San Giovanni Addolorata Hospital

OTHER

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

Medical University of Warsaw

OTHER

Sponsor Role: collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

Hospital San Carlos, Madrid

OTHER

Sponsor Role: collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: collaborator

McMaster University Health Sciences Centre

UNKNOWN

Sponsor Role: collaborator

Fujita Health University

OTHER

Sponsor Role: collaborator

Harbin Medical University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: collaborator

Fundación de Investigación Biomédica - Hospital Universitario de La Princesa

OTHER

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

Radbound University Medical Center

UNKNOWN

Sponsor Role: collaborator

Department of Cardiovascular Surgery, German Heart Center Munich

UNKNOWN

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: collaborator

The Queen Elizabeth Hospital

OTHER

Sponsor Role: collaborator

Yonsei University Hospital, Seoul, South Korea

UNKNOWN

Sponsor Role: collaborator

Nara Medical University

OTHER

Sponsor Role: collaborator

Shinshu University School of Medicine

UNKNOWN

Sponsor Role: collaborator

University Hospitals Sussex NHS Foundation Trust

UNKNOWN

Sponsor Role: collaborator

Galeazzi Sant'Ambrogio Hospital - Milan

UNKNOWN

Sponsor Role: collaborator

CORRIB Core Lab, University of Galway

UNKNOWN

Sponsor Role: collaborator

Queen Mary University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Queen Mary University of London

London, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Christos Bourantas

Role: CONTACT

c.bourantas@qmul.ac.uk

+442073777000

Andreas Baumbach

Role: CONTACT

Facility Contacts

Christos Bourantas

Role: primary

c.bourantas@qmul.ac.uk

+442073777000

References

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.

Reference Type: BACKGROUND

PMID: 31566246 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29576586 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26906566 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28711588 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26160628 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30293579 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28882287 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31215995 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24974809 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23856322 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24458955 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22723305 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28158723 (View on PubMed)

Other Identifiers

331221

Identifier Type: -

Identifier Source: org_study_id