Optimized strategy for percutaneous coronary intervention

Comparison of Fractional Flow Reserve-Guided Strategy Versus Intravascular Ultrasound-Guided Stent Implantation after Angiography-Derived Fractional Flow Reserve-based Decision-Making

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0009522

Enrollment

1936

Registered

2024-06-13

Start date

2024-06-01

Completion date

Unknown

Last updated

2024-06-24

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 : In the control group, the decision to perform PCI (Percutaneous Coronary Intervention) will be based on invasively measured Fractional Flow Reserve (FFR), a method recommended by inte

398:2149-2159). Therefore, the current study's experimental group poses no additional risk to patients compared to those receiving PCI based solely on conventional coronary angiography, and it is expe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Subject must be = 19 years. ? Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI with a drug-eluting stent (DES) and he/she or his/her legally authorized representative provides written informed consent. ? Subjects suspected with ischemic heart disease. ? Subjects with coronary artery diameter stenosis 50-90% by angiography-based visual estimation eligible for stent implantation. ? Target vessel size = 2.5mm in visual estimation.

Exclusion criteria

Exclusion criteria: ? Known hypersensitivity or contraindication to any of the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor. ? Active pathologic bleeding. ? Gastrointestinal or genitourinary major bleeding within the prior 3 months. ? History of bleeding diathesis, known coagulopathy. ? Non-cardiac co-morbid conditions with life expectancy < 2 year. ? Target lesion located in coronary arterial bypass graft. ? Left main coronary artery diameter stenosis = 50%. ? Chronic total occlusion in the study target vessel. ? Culprit lesion of STEMI ? Not eligible for angiography-derived FFR (ostial RCA = 50% stenosis, severe tortuosity, severe overlap, poor image quality)

Design outcomes

Primary

Measure	Time frame
POCO, defined as a composite of death from any cause, MI, or any revascularization	—

Secondary

Measure	Time frame
Individual component of POCO	—

Countries

Korea, Republic of

Contacts

Public ContactBon-Kwon KOO

Seoul National University Hospital

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

Outcome results