Use of Physiology to Evaluate Procedural Result After PCI CTO

ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for PCI CTO.

The main objective of the study is to evaluate both the value of post-PCI RFR and post-PCI FFR for detecting suboptimal stent result (SSR).

After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, coronary flow reserve (CFR) and index of microcirculatory resistance (IMR)) of the CTO vessel will be performed. Additional OCT will be performed directly or during a staged procedure within 4 ± 2 weeks when indicated (i.e. high contrast use, procedural duration, major dissection or other safety reasons according to the operator).

When intra-coronary physiologic assessment or OCT is not possible at all, the patients will not be included in the study.

When the operator decides to optimize the stent result (post-dilation or additional stenting), based on the OCT and/or physiology, post-PCI RFR and FFR should be repeated. For patients undergoing a clinically indicated FFR of a remaining intermediate stenosis (angiographically 30-90%) in a non-CTO vessel or major side branch of the CTO vessel within 4 weeks after the index procedure, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) will be repeated in the CTO vessel for exploratory objectives

At 4 ± 2 weeks follow-up, the occurrence of cardiovascular events and clinical classification will be assessed for secondary objectives

• Seattle Angina Questionnaire (SAQ) score at follow-up [Срок оценки: 4± 2 weeks]
• New York Heart Association (NYHA) classification at follow-up [Срок оценки: 4± 2 weeks]
• Canadian Cardiovascular Society (CCS) classification at follow-up [Срок оценки: 4± 2 weeks]
• Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at follow-up [Срок оценки: 4± 2 weeks]
• The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients. [Срок оценки: Index procedure (or staged procedure if indicated).]
• The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) with regard to SSR following angiographically satisfactory CTO PCI. [Срок оценки: Index procedure (or staged procedure if indicated).]
• The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score), NYHA and CCS classification and MACE at follow-up [Срок оценки: Index procedure (or staged procedure if indicated) until 4± 2 weeks follow-up]
• The impact on physician-decision making based on OCT and physiology findings [Срок оценки: Index procedure (or staged procedure if indicated).]