Use of Physiology to Evaluate Procedural Result After PCI CTO
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: post-PCI Pd/Pa.
- Who it may be relevant to
- Registry conditions: Percutaneous Coronary Revascularisation, Complex Coronary Lesion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
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
Interventions
- Diagnostic test post-PCI Pd/Pa
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.
Primary outcome measures
- The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR. [Time frame: Index procedure (or staged procedure if indicated).]
Secondary outcome measures (8)
- Seattle Angina Questionnaire (SAQ) score at follow-up [Time frame: 4± 2 weeks]
- New York Heart Association (NYHA) classification at follow-up [Time frame: 4± 2 weeks]
- Canadian Cardiovascular Society (CCS) classification 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: 4± 2 weeks]
- 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).]
- 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) until 4± 2 weeks follow-up]
- The impact on physician-decision making based on OCT and physiology findings [Time frame: Index procedure (or staged procedure if indicated).]
Eligibility criteria
Inclusion criteria
- Age 18 years and older.
- Angiographically successful PCI CTO without any remaining lesion at least 30% proximal to the stented segment.
- Possibility to perform physiologic measurements and OCT of sufficient quality.
- Patients willing and capable to provide written informed consent.
Exclusion criteria
1\) Contra-indication for adenosine.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Netherlands · 2 centers
- Radboud UMC — Nijmegen
- Isala — Zwolle
Publications
- Griffioen AM, Meijers TA, Roolvink V, van der Heijden DJ, Volleberg RHJA, van Wely M, van Royen N, van Geuns RJ, van Leeuwen M. 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. BMJ Open. 2025 Nov 27;15(11):e108995. doi: 10.1136/bmjopen-2025-108995. PMID 41309467
Identifiers
NCT: NCT04780971 · 9346