NCT03338309Active, not recruiting
INsTantenous wavE-Free Ratio-guided PCI Versus Fractional Flow REserve-Guided PCI in rouTine Clinical Practice, Prospective, Multicenter Registry
Multicenter Registry for Instantaneous Wave-Free Ratio (iFR)-Guided Percutaneous Coronary Intervention in Routine Clinical Practice
Source: ClinicalTrials.gov · Last updated 14 Mar 2025
Brief summary (registry, in English)
The current study sought to evaluate the clinical relevance of iFR-guided strategy in real world clinical practice using unrestricted study population from stable angina to acute coronary syndrome including acute ST-segment elevation myocardial infarction. Previous abundant historical data of FFR-guided strategy will be also included as historical control to validate the iFR-guided strategy.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 1200 (actual)
- First submitted
- 7 Nov 2017
- Start date
- 1 Nov 2017
- Primary completion date
- 1 Dec 2025
- Lead sponsor
- Samsung Medical Center
- Diseases
- Coronary artery disease
- NCT number
- NCT03338309
What you commit to
- Study type: Observational
- Participants enrolled: 1200
- From 1 Nov 2017 to the primary completion date, 1 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.
Prior treatment
- Cardiogenic shock (systolic blood pressure \< 90mmHg or requiring inotropics to maintain blood pressure \> 90mmHg)
- Patients with a known hypersensitivity or contraindication to any of the following medications: statin, ezetimibe, heparin, aspirin, clopidogrel, prasugrel, ticagrelor ③ Non-cardiac co-morbid conditions are present with life expectancy \<2 year (per site investigator's medical judgment).
- History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia)
- Patients with active pathologic bleeding ⑥ Gastrointestinal or genitourinary major bleeding within the prior 3 months. ⑦ Target lesion located in coronary arterial bypass graft
Who the study is looking for
- Subject must be ≥18 years
- Patients suspected with ischemic heart disease ③ Patients with coronary artery stenosis with intermediate degree of stenosis (40-70% stenosis by visual estimation) in major epicardial coronary artery amenable to stent implantation or vessel size≥2.5 mm without definitive previous evidence of myocardial ischemia.
- Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic evaluation and he/she or his/her legally authorized representative provides
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 | 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.