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. 2025 Nov 27;15(11):e108995.
doi: 10.1136/bmjopen-2025-108995.

Use of physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion (ULTRA-CTO): protocol for a prospective, single-arm, multicentre, exploratory study

Alexander M Griffioen  1 , Thomas A Meijers  2 , Vincent Roolvink  2 , Dirk J van der Heijden  2 , Rick H J A Volleberg  1 , Marleen van Wely  1 , Niels van Royen  1 , Robert-Jan van Geuns  1 , Maarten van Leeuwen  3
Affiliations

Use of physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion (ULTRA-CTO): protocol for a prospective, single-arm, multicentre, exploratory study

Alexander M Griffioen et al. BMJ Open. .

Abstract

Introduction: Post-percutaneous coronary intervention (PCI) fractional flow reserve (FFR) is associated with future major adverse cardiac events and may reflect residual ischaemia and suboptimal stent result (SSR). Post-PCI FFR should therefore be considered to identify patients at high risk. Whether abnormal post-PCI FFR and non-hyperaemic pressure ratios, including resting full-cycle ratio (RFR), represent SSR after PCI remains to be determined, especially after chronic total occlusion (CTO) PCI. In addition, little is known about the association between post-PCI intracoronary physiology and SSR with residual anginal complaints.

Methods and analysis: The physioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion study is a prospective, multicentre, exploratory, mechanistic, investigator-initiated, single-arm study with a non-inferiority design. A total of 200 patients, undergoing CTO PCI, with FFR and RFR measured in all patients, will be included at two study sites in the Netherlands. The primary endpoint is the area under the curve (AUC) of post-PCI RFR, in comparison to the AUC of post-PCI FFR, for prediction of optical coherence tomography-detected SSR and its individual components.

Ethics and dissemination: The study is approved by the local ethical review board ('Medisch Ethische Toetsing Commissie Isala Zwolle'). Written informed consent will be obtained from all patients before enrolment. The outcomes of this study are intended to be disseminated in a peer-reviewed journal.

Study registration: NCT04780971.

Keywords: Coronary heart disease; Coronary intervention; Ischaemic heart disease.

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Conflict of interest statement

Competing interests: NvR reported receiving grant funding and personal fees from Abbott Vascular and Health-Holland and grants from Philips, Biotronik and Medtronic Inc, and speaker fees from Bayer AG, MicroPort and RainMed Medical. R-JvG reported receiving grant funding from InfraRedx, and speaker fees from Amgen and Sanofi. MvL reported receiving grant funding from AstraZeneca, Top Sector Life Sciences & Health, Terumo Corporation, TOP Medical BV and Abbott Laboratories and speakers’ fees and consulting from Terumo Corporation, Daiichi Sankyo Inc and Abbott Laboratories. All other authors have reported that there are no conflicts of interest in relation to this particular manuscript to declare.

Figures

Figure 1
Figure 1. PhysioLogy to evaluaTe procedural Result After percutaneous coronary intervention of Chronic Total Occlusion study design. CTO, chronic total occlusion; FFR, fractional flow reserve; MLA, mean reference lumen area; MSA, minimal stent area; OCT, optical coherence tomography; RFR, resting full-cycle ratio; PCI, percutaneous coronary intervention.
Figure 2
Figure 2. Study flowchart. CTO, chronic total occlusion; FFR, fractional flow reserve; MACE, major adverse cardiovascular event; NYHA, New York Heart Association; OCT, optical coherence tomography; RFR, resting full-cycle ratio; PCI, percutaneous coronary intervention; SAQ, Seattle Angina Questionnaire.
See this image and copyright information in PMC

References

    1. van Bommel RJ, Masdjedi K, Diletti R, et al. Routine Fractional Flow Reserve Measurement After Percutaneous Coronary Intervention. Circ Cardiovasc Interv. 2019;12:e007428. doi: 10.1161/CIRCINTERVENTIONS.118.007428. - DOI - PubMed
    1. Wolfrum M, Fahrni G, de Maria GL, et al. Impact of impaired fractional flow reserve after coronary interventions on outcomes: a systematic review and meta-analysis. BMC Cardiovasc Disord. 2016;16:177. doi: 10.1186/s12872-016-0355-7. - DOI - PMC - PubMed
    1. Johnson NP, Tóth GG, Lai D, et al. Prognostic value of fractional flow reserve: linking physiologic severity to clinical outcomes. J Am Coll Cardiol. 2014;64:1641–54. doi: 10.1016/j.jacc.2014.07.973. - DOI - PubMed
    1. Griffioen AM, van den Oord SCH, Teerenstra S, et al. Clinical Relevance of Impaired Physiological Assessment After Percutaneous Coronary Intervention: A Meta-analysis. Journal of the Society for Cardiovascular Angiography & Interventions. 2022;1:100448. doi: 10.1016/j.jscai.2022.100448. - DOI - PMC - PubMed
    1. Uretsky BF, Agarwal SK, Vallurupalli S, et al. Trans-Stent FFR Gradient as a Modifiable Integrant in Predicting Long-Term Target Vessel Failure. JACC Cardiovasc Interv. 2022;15:2192–202. doi: 10.1016/j.jcin.2022.08.036. - DOI - PubMed

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