Stent ThrombosisTISIS registryNCT06700018
Flow Patterns and Stent Thrombosis
An observational study of Stent Thrombosis, run by Queen Mary University of London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stent Thrombosis
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Apr 2024to 31 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 120 patients who have undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent
Who may be able to join
- Patients undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent
- Patients who have suffered thrombosis post-stent implantation
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Novel Method for Detailed Evaluation of Blood Flow Patterns in Stented Segments and Assessment of Their Role in 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.
Read the 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
- Keywords
- stent thrombosis, endothelial shear stress, optical coherence tomography, blood flow simulations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1.5 years
Secondary outcomes (3)
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
Measured: 3 months
Validation of the proposed reconstruction methodology
To validate in vivo and in-bench studies, the accuracy of the developed reconstruction method.
Measured: 4 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2024
- Study start1 Apr 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Stent ThrombosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Barts & The London NHS Trust, Oxford University Hospitals NHS Trust, Royal Free Hospital NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust, Manchester University NHS Foundation Trust, King's College Hospital NHS Trust, San Giovanni Addolorata Hospital, Medstar Health Research Institute, Medical University of Warsaw, Insel Gruppe AG, University Hospital Bern, Hospital San Carlos, Madrid, The Leeds Teaching Hospitals NHS Trust, McMaster University Health Sciences Centre, Fujita Health University, Harbin Medical University, Yale University, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Erasmus Medical Center, Radboud University Medical Center, Department of Cardiovascular Surgery, German Heart Center Munich, Columbia University, The Queen Elizabeth Hospital, Yonsei University Hospital, Seoul, South Korea, Nara Medical University, Shinshu University School of Medicine, University Hospitals Sussex NHS Foundation Trust, Galeazzi Sant'Ambrogio Hospital - Milan, CORRIB Core Lab, University of Galway
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700018
- Sponsor's protocol ID
- 331221
- Acronym
- TISIS registry
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data sharing has not been decided yet. It may be considered in the future.
Publications
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.
PubMed 31566246Li 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.
PubMed 29576586O'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.
PubMed 26906566Migliori 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.
PubMed 28711588Li 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.
PubMed 26160628Torii 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.
PubMed 30293579Tenekecioglu 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.
PubMed 28882287Torii 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.
PubMed 31215995Papafaklis 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.
PubMed 24974809Papafaklis 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.
PubMed 23856322Bourantas 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.
PubMed 24458955Stone 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.
PubMed 22723305Thondapu 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.
PubMed 28158723
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Novel Method for Detailed Evaluation of Blood Flow Patterns in Stented Segments and Assessment of Their Role in Stent Thrombosis
- ClinicalTrials.gov ID
- NCT06700018
- Acronym / sponsor ID
- TISIS registry / 331221
- Conditions
- Stent Thrombosis
- Keywords
- stent thrombosis, endothelial shear stress, optical coherence tomography, blood flow simulations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Barts & The London NHS Trust, Oxford University Hospitals NHS Trust, Royal Free Hospital NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Mid and South Essex NHS Foundation Trust, Newcastle-upon-Tyne Hospitals NHS Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust, Manchester University NHS Foundation Trust, King's College Hospital NHS Trust, San Giovanni Addolorata Hospital, Medstar Health Research Institute, Medical University of Warsaw, Insel Gruppe AG, University Hospital Bern, Hospital San Carlos, Madrid, The Leeds Teaching Hospitals NHS Trust, McMaster University Health Sciences Centre, Fujita Health University, Harbin Medical University, Yale University, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Erasmus Medical Center, Radboud University Medical Center, Department of Cardiovascular Surgery, German Heart Center Munich, Columbia University, The Queen Elizabeth Hospital, Yonsei University Hospital, Seoul, South Korea, Nara Medical University, Shinshu University School of Medicine, University Hospitals Sussex NHS Foundation Trust, Galeazzi Sant'Ambrogio Hospital - Milan, CORRIB Core Lab, University of Galway
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 21 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 120 patients who have undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent
Key inclusion criteria (2 listed)
- Patients undergone OCT-guided percutaneous coronary intervention and implanted with a second-generation drug-eluting stent
- Patients who have suffered thrombosis post-stent implantation
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
OCT based stented segment reconstruction
Time frame: 3 months
Validation of the proposed reconstruction methodology
Time frame: 4 months
Development of automated frame work for reconstruction of stented segments
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 31566246Gijsen 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.
- Background: PubMed 29576586Li 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.
- Background: PubMed 26906566O'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.
- Background: PubMed 28711588Migliori 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.
- Background: PubMed 26160628Li 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.
- Background: PubMed 30293579Torii 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.
- Background: PubMed 28882287Tenekecioglu 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.
- Background: PubMed 31215995Torii 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.
- Background: PubMed 24974809Papafaklis 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.
- Background: PubMed 23856322Papafaklis 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.
- Background: PubMed 24458955Bourantas 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.
- Background: PubMed 22723305Stone 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.
- Individual participant dataSharing planned: Undecided. The data sharing has not been decided yet. It may be considered in the future.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stent Thrombosis, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamic shear stress and shear rate (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06700018, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.