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.
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.
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.
We will recruit 478 paediatric patients with newly diagnosed IgAV across multiple centres. Participants will undergo prospective longitudinal assessment at disease onset and at 1, 3, 6 and 12 months postdiagnosis. Standardised evaluations will include clinical manifestations, physical examinations, laboratory parameters and patient-reported outcomes. The data will be analysed statistically with SPSS software (V.27.0), adopting a significance threshold of p
This study has been approved by the Medical Ethics Committee of the First Affiliated Hospital of Guangxi Medical University (2024-K0480), the Ethics Committee of the First People’s Hospital of Yulin (YLSY-IRB-SR-2025060), the Medical Research Ethics Committee of the Liuzhou Workers’ Hospital (KY2024356) and the Ethics Committee of the Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region (No. (2025–1)003) and written informed consent was obtained from all the parents or guardians of the patients involved. It will be disseminated by publication of peer-reviewed manuscripts and presentation in abstract form at national and international scientific meetings.
ChiCTR2500099716.