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

Vilnius University Hospital Santaros Klinikos80 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Coronary Artery Disease

Interventions

FFR and IVUS guided PCIPROCEDURE

PCI to the long lesion guided with FFR and IVUS

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Vilnius University Hospital Santaros Klinikos

Vilnius, Lithuania

Outcomes

Primary Outcomes

The proportion of patients with optimal physiology result

Post PCI FFR value ≥ 0.9

Time frame: 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.

Time frame: 1 day

The proportion of patients with optimal physiology and anatomy result

Post PCI FFR value ≥ 0.9 and all four IVUS criteria met

Time frame: 1 day

Secondary Outcomes

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))

Time frame: 12 months post PCI follow up

Data from ClinicalTrials.gov

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