Use of Physiology to Evaluate Procedural Result After PCI CTO

Study Overview
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Brief Summary
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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 and who have at least one intermediate (angiographically 30-90%) stenosis in a non-CTO vessel or major side branch of the CTO vessel with a diameter of at least 2 mm. 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
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ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for PCI CTO and who have at least one intermediate (angiographically 30-90%) stenosis in a non-CTO vessel or major side branch of the CTO vessel with a diameter of at least 2mm. 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) in the acute phase and the stability of these measurements over time. 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 directly. A staged procedure including several measurements is planned at 4 ± 2 weeks after the index procedure. These measurements include same intra-coronary physiologic measurements as performed at index procedure and optical coherence tomography (OCT) imaging of the stented segment in the CTO target vessel. Prior to the staged procedure occurrence of cardiovascular events and clinical classification will be assessed.

Official Title
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Use of Physiology to Evaluate Procedural Result After PCI CTO

Conditions
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Percutaneous Coronary Revascularisation, Complex Coronary Lesion

Intervention / Treatment
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* Diagnostic Test: post-PCI Pd/Pa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years and older. Presence of at least one intermediate (angiographically 30-90%) stenosis in the non-CTO vessel or major side branch of the CTO vessel with diameter of at least 2mm, for which FFR is clinically indicated. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Post-PCI intra-coronary physiological and OCT measurements<br>After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) of the CTO vessel will be performed directly. A staged procedure including several measurements is planned at 4 ± 2 weeks after the index procedure. These measurements consists of the same intra-coronary physiologic assessments at index procedure and OCT imaging of the stented segment in the CTO target vessel. | Diagnostic Test: post-PCI Pd/Pa<br>* After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) of the CTO vessel will be performed directly. A staged procedure including several measurements is planned at 4 ± 2 weeks after the index procedure. These measurements consists of the same intra-coronary physiologic assessments at index procedure and OCT imaging of the stented segment in the CTO target vessel.<br>* Other names: Post-PCI OCT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR. | The AUC of post-PCI RFR compared to the AUC of post-PCI FFR with regard to SSR. | Index and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seattle Angina Questionnaire (SAQ) score at 4 weeks | Seattle Angina Questionnaire (SAQ) score at 4 weeks | 4 weeks | 
| New York Heart Association (NYHA) classification at 4 weeks | New York Heart Association (NYHA) classification (I, II, III or IV) at 4 weeks | 4 weeks | 
| Canadian Cardiovascular Society (CCS) classification at 4 weeks | Canadian Cardiovascular Society (CCS) classification (I, II, III, IV) at 4 weeks | 4 weeks | 
| Occurrence of target lesion revascularization (TLR) at 4 weeks | Occurrence of target lesion revascularization (TLR) at 4 weeks | 4 weeks | 
| Occurrence of stent thrombosis (ST) at 4 weeks | Occurrence of stent thrombosis (ST) at 4 weeks | 4 weeks | 
| Occurrence of target vessel failure (TVF) at 4 weeks | Occurrence of target vessel failure (TVF) at 4 weeks | 4 weeks | 
| Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at 4 weeks | Occurrence of the composite endpoint of all-cause mortality, myocardial infarction and any coronary revascularization (MACE) at 4 weeks | 4 weeks | 
| The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients. | The predictive value of the RFR and FFR gradient across the stented segment with regard to SSR in CTO patients. | Index PCI CTO until staged procedure at 4 weeks | 
| The correlation of post-PCI RFR and -FFR with SSR at 4 weeks. | The correlation of post-PCI RFR and -FFR with SSR at 4 weeks. | During staged procedure (4 weeks after index CTO PCI) | 
| The change in resting full-cycle ratio (RFR) over a period of 4 weeks after CTO PCI. | The change in resting full-cycle ratio (RFR) over a period of 4 weeks after CTO PCI. | Index PCI CTO until staged procedure at 4 weeks | 
| The change in fractional flow reserve (FFR) over a period of 4 weeks after CTO PCI. | The change in fractional flow reserve (FFR) over a period of 4 weeks after CTO PCI. | Index PCI CTO until staged procedure at 4 weeks | 
| The change in pressure-distal / pressure-aorta (Pd/Pa) over a period of 4 weeks after CTO PCI. | The change in pressure-distal / pressure-aorta = ratio of mean resting distal coronary pressure to aortic pressure (Pd/Pa) over a period of 4 weeks after CTO PCI. | Index PCI CTO until staged procedure at 4 weeks | 
| The change in coronary flow reserve (CFR) over a period of 4 weeks after CTO PCI. | The change in coronary flow reserve (CFR) over a period of 4 weeks after CTO PCI. | Index PCI CTO until staged procedure at 4 weeks | 
| The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) following angiographically satisfactory CTO PCI. | The correlation between positive RFR (≤0.89) and positive FFR (≤0.80) following angiographically satisfactory CTO PCI. | During index CTO PCI | 
| The incidence and change of microvascular dysfunction as assessed by IMR over a period of 4 weeks after CTO PCI. | The incidence and change of microvascular dysfunction as assessed by IMR over a period of 4 weeks after CTO PCI. | Index PCI CTO until staged procedure at 4 weeks | 
| The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score) at 4 weeks. | The correlation between post-PCI physiology (OCT, RFR, FFR, CFR, IMR) and suboptimal stent result (SSR) with anginal complaints (SAQ score) at 4 weeks. | During staged procedure (4 weeks after index CTO PCI) | 
| The impact on physician-decision making based on OCT and physiology findings at 4 weeks. | The impact on physician-decision making based on OCT and physiology findings at 4 weeks. | During staged procedure (4 weeks after index CTO PCI) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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percutaneous coronary intervention, chronic total occlusion, intra-coronary physiology, optical coherence tomography