NCT03030495Active, not recruiting
Registry of Comprehensive Imaging and Physiological Evaluation of Deferred Lesions Based on FFR
IMaging and Physiologic Predictors of Atherosclerotic Progression in Deferred Lesions With Contemporary Medical Treatment Based on Fractional Flow Reserve-guided Strategy
Source: ClinicalTrials.gov · Last updated 15 May 2025
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1400 (estimated)
- First submitted
- 20 Dec 2016
- Start date
- 1 Dec 2016
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT03030495
What you commit to
- Study type: Observational
- Planned participants: 1400
- From 1 Dec 2016 to the primary completion date, 31 Dec 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Lab values
- End-staged renal disease on peritoneal dialysis or hemodialysis (estimated GFR \< 15mL/min)
Other
- Acute hepatic injury
- Cardiogenic shock (systolic blood pressure \< 90mmHg or requiring inotropics to maintain blood pressure \> 90mmHg)
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Keimyung University - Dongsan Medical Center Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Inje University Ilsan Paik Hospital Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.