The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology

Study Overview
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Brief Summary
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Following successful CTO PCI, a multitude of physiological and anatomical changes take place. Contemporary techniques such as dissection/re-entry or lumen-lumen wiring may influence the immediate and longer term follow up of these features. It is not known whether changes in this level of physiology and anatomy in the context of CTO vessels correlate with each other, or with quality of life and exercise capacity. This study aims to take physiological measurements of absolute coronary flow, resistance and pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators will relate these to each other and to the method of revascularisation, comparing changes in these groups at three months follow up. QoL measurements, and exercise testing will be carried out to see if there is a relationship between physiological and anatomical changes with exercise capacity and quality of life. Results from this study could shed light on optimisation of CTO PCI procedural and clinical outcomes.

Detailed Description
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Following successful chronic total occlusion (CTO) percutaneous coronary intervention (PCI), a multitude of physiological and anatomical changes take place. Contemporary techniques such as dissection/re-entry or lumen-lumen wiring may influence the immediate and longer term follow up of these features. It is not known whether changes in this level of physiology and anatomy in the context of CTO vessels correlate with each other, or with quality of life and exercise capacity. This study aims to take physiological measurements of absolute coronary flow, resistance and pressure and intra-coronary imaging immediately after successful CTO PCI. The investigators will relate these to each other and to the method of revascularisation, comparing changes in these groups at three months follow up. Quality of life measurements, and exercise testing will be carried out to see if there is a relationship between physiological and anatomical changes with exercise capacity and quality of life. Results from this study could shed light on optimisation of CTO PCI procedural and clinical outcomes.

Official Title
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The Impact of Coronary Chronic Total Occlusion Percutaneous Coronary Intervention on Culprit Vessel Physiology

Conditions
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Chronic Total Occlusion of Coronary Artery

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age Presence of a coronary chronic total occlusion (CTO) scheduled for elective percutaneous coronary angioplasty (PCI) Evidence of viability in the CTO Territory Exclusion Criteria: < 18 year of age Unable to give informed consent Known severe chronic kidney disease (creatinine clearance ≤30 mL/min), unless the patient is on dialysis Unable to receive antiplatelets or periprocedural anticoagulation Contraindications to adenosine Any study lesion characteristic resulting in the expected inability to deliver FD-OCT catheter at the distal vessel post CTO PCI (e.g. moderate or severe vessel calcification or tortuosity) Pregnancy, planning pregnancy during study period, or breastfeeding

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Successful CTO PCI achieved<br>Patients will have successful CTO PCI (chronic total occlusion percutaneous coronary intervention) followed by physiological and intracoronary imaging. These measurements will be repeated at a 3 month follow up angiogram procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in coronary flow | change in coronary flow at baseline and follow up | 3 months | 
| Change in coronary resistance | change in coronary absolute resistance at baseline and follow up | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in coronary anatomy | To identify intracoronary anatomical features between baseline and follow up. | 3 months | 
| Change in exercise work load | Change in exercise work measured in METS (metabolic equivalents). | 3 months | 
| Change in quality of life | change in quality measured by the validated Seattle angina seven question questionnaire from baseline to follow up. This is a scale based on 7 questions giving scores of 0-100 on physical limitation, angina, and quality of life, with the average of these scores giving a mean value also ranging from 0-100 of the overall summary score. | 3 months | 
| Change in coronary pressure measurements | change in fractional flow reserve (FFR) at baseline and follow up | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CTO - chronic total occlusion, OCT - optical coherence tomography, coronary physiology, absolute flow