The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions

Study Overview
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Brief Summary
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A single center, prospective, observational study to investigate the impact of intravascular ultrasound (IVUS) on the functional percutaneous coronary intervention (PCI) result (assessed with fractional flow reserve (FFR)) and one-year target vessel failure (TVF) rate after percutaneous treatment of long coronary artery lesions

Official Title
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The Implementation of Intravascular Ultrasound and Fractional Flow Reserve in the Percutaneous Treatment of Very Long Coronary Artery Lesions

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: FFR and IVUS guided PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic coronary syndrome (stable angina; staged PCI to other lesions after acute myocardial infarction with ST segment elevation); Acute coronary syndrome without ST segment elevation (unstable angina or myocardial infarction without ST segment elevation); Functionally significant (FFR ≤ 0.8) lesion requiring a stent length of ≥ 30 mm and amenable for percutaneous coronary intervention. Exclusion Criteria: Patient's age ≤ 18 years; Acute myocardial infarction with ST segment elevation; Treatment with dual antiplatelet therapy contraindicated; Survival expectancy ≤ 1 year; Known allergy to sirolimus, everolimus or zotarolimus.

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 |
| --- | --- |
| Patients with long coronary artery lesions<br>Consecutive patients with functionally significant (FFR ≤ 0.8) long lesion requiring a stent length of ≥ 30mm to undergo FFR and IVUS guided PCI. | Procedure: FFR and IVUS guided PCI<br>* PCI to the long lesion guided with FFR and IVUS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients with optimal physiology result | Post PCI FFR value ≥ 0.9 | 1 day | 
| The proportion of patients with optimal anatomy result | If all the four following IVUS criteria met: (1) good stent apposition; (2) good stent expansion (minimal stent area (MSA) >90% of distal reference lumen area and/or MSA ≥5.5mm2); (3) plaque burden 5mm proximal and distal to the stent <50%); (4) no stent edge dissection. | 1 day | 
| The proportion of patients with optimal physiology and anatomy result | Post PCI FFR value ≥ 0.9 and all four IVUS criteria met | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of target vessel failure (TVF) | Composite endpoint (target vessel related death (TV-death), target vessel related myocardial infarction (TV-MI), ischemia driven target vessel revascularization (TV-R)) | 12 months post PCI follow up |