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NCT Number: NCT03338309

INsTantenous wavE-Free Ratio-guided PCI Versus Fractional Flow REserve-Guided PCI in rouTine Clinical Practice, Prospective, Multicenter Registry

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.

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Key information

About this study

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 iFR measurement will be prospectively enrolled at 5 centers in Republic of Korea. In patients who were indicated revascularization after iFR measurement (iFR<0.90), iFR pullback system (iFR Scout) and post-revascularization iFR measurement will be routinely performed. The primary hypothesis will be tested for non-inferiority of iFR-guided strategy, compared with FFR-guided strategy in terms of 2-year clinical outcomes. For the clinical outcome data following FFR-guided strategy will be used from the pooled data of the DEFER-DES trial, the 3V FFR FRIENDS registry (NCT01621438), and Korean 4-center FFR registry. Using those data, 1200 patients will be selected from the pooled data. In addition, routine application of iFR Scout and post-revascularization iFR measurement will enable us to validate the clinical relevance of iFR-based prediction of acute procedural results and to compare FFR-pullback methods.

Primary Hypothesis: The iFR-guided strategy will be non-inferior regarding patient-oriented composite outcomes (a composite of any death, any MI, any revascularization) at 2-year, compared with FFR-guided strategy.

Primary Outcome:

1] Patient-oriented composite outcome (POCO), defined as a composite of any death, any myocardial infarction (MI) or any revascularization at 2-year after index procedure according to the ARC consensus [2] Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement

Sample Size 1,200 patients with suspected ischemic heart disease including stable angina, or acute coronary syndrome including unstable angina, non ST-segment elevation MI, or ST-segment elevation MI with non-culprit stenosis enrolled at 5 centers in Republic of Korea.

  • Inclusion Criteria

① Subject must be ≥18 years

② 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.

④ 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 criteria
  • Cardiogenic shock (systolic blood pressure < 90mmHg or requiring inotropics to maintain blood pressure > 90mmHg) ② Patients with 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).
  • History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia) ⑤ 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 can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Instantaneous wave-free ratio measurement

Other

Instantaneous wave-free ratio measurement in order to evaluate functional significance of epicardial stenosis

Primary outcomes

  1. Patient-oriented composite outcome (POCO)

    Time frame: at 2-year after index procedure

    a composite of any death, any myocardial infarction (MI) or any revascularization according to the ARC consensus

Secondary outcomes

  1. Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement

    Time frame: Immediate after post revascularization

    Difference between Predicted post-PCI iFR value from iFR Scout and Actual post-PCI iFR measurement

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Philips Healthcare
  • Seoul National University Hospital

Registry information

Official study title

Multicenter Registry for Instantaneous Wave-Free Ratio (iFR)-Guided Percutaneous Coronary Intervention in Routine Clinical Practice

Acronym: INTERPRET

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Nov 9, 2017
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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