Complex Coronary Lesion, Percutaneous Coronary Revascularisation
Conditions
Keywords
percutaneous coronary intervention, chronic total occlusion, intra-coronary physiology, optical coherence tomography
Brief summary
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_TESTpost-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.
Sponsors
Abbott
Isala
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 years and older. 2. Angiographically successful PCI CTO without any remaining lesion at least 30% proximal to the stented segment. 3. Possibility to perform physiologic measurements and OCT of sufficient quality. 4. Patients willing and capable to provide written informed consent.
Exclusion criteria
1\) Contra-indication for adenosine.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| New York Heart Association (NYHA) classification at follow-up | 4± 2 weeks | New York Heart Association (NYHA) classification (I, II, III or IV) at follow-up |
| Canadian Cardiovascular Society (CCS) classification at follow-up | 4± 2 weeks | Canadian Cardiovascular Society (CCS) classification (I, II, III, IV) at follow-up |
| Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at follow-up | 4± 2 weeks | Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at follow-up |
| Seattle Angina Questionnaire (SAQ) score at follow-up | 4± 2 weeks | Seattle Angina Questionnaire (SAQ) score at follow-up |
| The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) with regard to SSR following angiographically satisfactory CTO PCI. | 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. |
| 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 | 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. |
| The impact on physician-decision making based on OCT and physiology findings | Index procedure (or staged procedure if indicated). | The impact on physician-decision making based on OCT and physiology findings |
| The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients. | 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. |
Countries
Netherlands
Contacts
Primary ContactMaarten van Leeuwen, PhD
Outcome results
None listed