NCT Number: NCT04780971
ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for percutaneous coronary intervention (PCI) of chronic total occluded (CTO) coronary artery.
The main objective of the study is to assess the predictive value of post-PCI resting full-cycle ratio (RFR) and fractional flow reserve (FFR) with regard to Fractional flow reserve (SSR) in CTO patients.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Radboud UMC, Nijmegen, Netherlands
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) and subsequent OCT of the CTO vessel will be performed. OCT may also be performed during a staged procedure when clinically indicated.
Other names: Post-PCI RFR, Post-PCI CFR, Post-PCI IMR, Post-PCI FFR, Post-PCI OCT
Time frame: Index procedure (or staged procedure if indicated).
The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR.
Time frame: 4± 2 weeks
Seattle Angina Questionnaire (SAQ) score at follow-up
Time frame: 4± 2 weeks
New York Heart Association (NYHA) classification (I, II, III or IV) at follow-up
Time frame: 4± 2 weeks
Canadian Cardiovascular Society (CCS) classification (I, II, III, IV) at follow-up
Time frame: 4± 2 weeks
Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at follow-up
Time frame: Index procedure (or staged procedure if indicated).
The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients.
Time frame: 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.
Time frame: Index procedure (or staged procedure if indicated) until 4± 2 weeks follow-up
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.
Time frame: Index procedure (or staged procedure if indicated).
The impact on physician-decision making based on OCT and physiology findings
Contact information is provided by the study sponsor or research team.
Isala
Other
Acronym: ULTRA-CTO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
