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

NCT03338309 | Active Not Recruiting DMC

• 1 other identifier: NCT104658359911
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Stable Angina; Non ST Segment Elevation Myocardial Infarction; ST-segment Elevation Myocardial Infarction; Silent Myocardial Ischemia; Unstable Angina

Keywords

Fractional flow reserve; Instantaneous wave-free ratio; Ischemic heart disease

Outcome Measures

Primary Outcomes (1)

• Patient-oriented composite outcome (POCO)

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

  at 2-year after index procedure

Secondary Outcomes (1)

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

  Immediate after post revascularization

Study Arms (1)

iFR-guied strategy group

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 who underwent iFR measurement and enrolled at 5 centers in Republic of Korea.

Other: Instantaneous wave-free ratio measurement

Interventions

Instantaneous wave-free ratio measurement OTHER

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

iFR-guied strategy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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 who underwent iFR measurement and enrolled at 5 centers in Republic of Korea.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Seoul National University Hospital: collaborator
• Philips Healthcare: collaborator

Study Sites (4)

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Angina, Stable; ST Elevation Myocardial Infarction; Angina, Unstable; Myocardial Ischemia

Condition Hierarchy (Ancestors)

Angina Pectoris; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  STUDY CHAIR

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  STUDY DIRECTOR

• Bon-Kwon Koo, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 7, 2017
• First Posted: November 9, 2017
• Study Start: November 1, 2017
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

KR (4)