Ireland
--:--IST
Active, not recruiting Observational

Registry of Comprehensive Imaging and Physiological Evaluation of Deferred Lesions Based on FFR

NCT03030495 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2016-12-01
Last updated
2025-05-15

Condition(s) studied

Ischemic Heart Disease

Investigational drug(s) / intervention(s)

Comprehensive physiologic evaluationIntravascular imaging devices

Comprehensive physiologic evaluation: Comprehensive physiologic evaluation using pressure-temperature sensor wire to measure fractional flow reserve, coronary flow reserve, index of microcirculatory resistance

Intravascular imaging devices: Intravascular ultrasound or optical coherence tomography

Study summary

1. To compare the risk of atherosclerotic lesion progression and subsequent patient-oriented composite outcomes (all-cause mortality, any MI, or any Ischemia-driven repeat revascularization) between deferred lesions with or without over microvascular disease, defined as physiological classification
2. To explore independent predictors of atherosclerotic lesion progression in deferred lesions based on fractional flow reserve-guided strategy and treated by contemporary medical treatment

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Subject must be ≥ 18 years * Patients suspected with ischemic heart disease * Patients with intermediate degree of stenosis (30-70% stenosis by visual estimation) with fractional flow reserve of \>0.80 in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm * Patients whose coronary stenosis were evaluated by invasive imaging techniques (intravascular ultrasound and optical coherence tomography) and physiologic assessment (coronary flow reserve, index of microcirculatory resistance, and fractional flow reserve) * Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and he/she or his/her legally authorized representative provides written informed consent to any study related procedure Exclusion Criteria: * End-staged renal disease on peritoneal dialysis or hemodialysis (estimated GFR \< 15mL/min) * Acute hepatic injury * Cardiogenic shock (systolic blood pressure \< 90mmHg or requiring inotropics to maintain blood pressure \> 90mmHg) * The patient has a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor * Non-cardiac co-morbid conditions are present with life expectancy \<2 year (per site investigator's medical judgment) * Unable to perform invasive imaging study (intravascular ultrasound and optical coherence tomography) or physiologic assessment (coronary flow reserve, index of microcirculatory resistance, and fractional flow reserve)

Primary outcome measure(s)

  • patient-oriented composite outcome — 24 months
    a composite of all-cause death, MI, any repeat revascularization

Trial sites (4)

FacilityCityRegionStatus
Keimyung University Dongsan Medical Center Daegu South Korea
Inje University Ilsan Paik Hospital Goyang-si South Korea
Samsung Medical Center Seoul South Korea
Seoul National University Hospital Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03030495 on ClinicalTrials.gov ↗ ← All trials in South Korea