Registry of Comprehensive Imaging and Physiological Evaluation of Deferred Lesions Based on FFR (NCT03030495) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Registry of Comprehensive Imaging and Physiological Evaluation of Deferred Lesions Based on FFR
South Korea1,400 participantsStarted 2016-12-01
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) …