Fractional FLow Reserve And IVUS for Clinical OUtcomes in Patients with InteRmediate Stenosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0003100

Enrollment

1700

Registered

2018-08-17

Start date

2016-07-14

Completion date

Unknown

Last updated

2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : For patients who meet the inclusion criteria and do not meet the exclusion criteria, and consent to participate in the study, the decision to perform stent implantation according to t

MLA = 3mm² or 3 70% in the IVUS-guided strategy group) will be made. In the FFR-guided strategy group, hyperemia will be induced using the standard method of intravenous adenosine infusion. In cases

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients aged 19 years or older ? Patients with moderate coronary artery stenosis on coronary angiography performed due to suspected ischemic heart disease, who need FFR or IVUS examination due to unclear evidence of myocardial ischemia ? Lesions with de novo moderate stenosis (40-70% stenosis by visual estimation) that are eligible for stent implantation, with the target vessel size visually estimated to be greater than 2.5 mm ? Target lesions are limited to the following coronary arteries: proximal/mid left anterior descending artery (pLAD, mLAD), proximal/mid left circumflex artery (pLCX, mLCX), and proximal/mid/distal right coronary artery (pRCA, mRCA, dRCA)

Exclusion criteria

Exclusion criteria: ? Patients who have a known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Contrast media (Patients with documented sensitivity to contrast media which can be effectively premedicated with steroids and diphenhydramine [e.g. rash] may be enrolled) ? Patients with active pathologic bleeding ? Gastrointestinal or genitourinary major bleeding within the prior 3 months. ? History of bleeding diathesis, known coagulopathy (including heparin-induced thrombocytopenia) ? Non-cardiac co-morbid conditions with life expectancy < 2 years ? Target lesion located in coronary arterial bypass graft ? Target lesion located in the left main coronary artery ? Target lesion located in previous PCI segment with in-stent restenosis

Design outcomes

Primary

Measure	Time frame
Patient-oriented composite outcome (POCO) defined as a composite of death from any cause, myocardial infarction, or any revascularization	—

Secondary

Measure	Time frame
Individual component of POCO	—

Countries

Korea, Republic of

Contacts

Public ContactBonkwon Koo

Seoul National University Hospital

bkkoo@snu.ac.kr+82-2-2072-2062

Outcome results