Status:
ACTIVE_NOT_RECRUITING
INsTantenous wavE-Free Ratio-guided PCI Versus Fractional Flow REserve-Guided PCI in rouTine Clinical Practice, Prospective, Multicenter Registry
Lead Sponsor:
Samsung Medical Center
Collaborating Sponsors:
Seoul National University Hospital
Philips Healthcare
Conditions:
Stable Angina
Non ST Segment Elevation Myocardial Infarction
Eligibility:
All Genders
18+ years
Brief Summary
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 inc...
Detailed Description
In this study, the investigators will validate the clinical relevance of instantaneous wave free ratio (iFR)-guided strategy in real world clinical practice in Korea. The 1,200 patients who underwent ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT03338309
Start Date
November 1 2017
End Date
December 1 2025
Last Update
March 14 2025
Active Locations (4)
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1
Keimyung University Dongsan Medical Center
Daegu, South Korea
2
Inje University Ilsan Paik Hospital
Goyang, South Korea
3
Samsung Medical Center
Seoul, South Korea
4
Seoul National University Hospital
Seoul, South Korea