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

Not Applicable

Recruiting

Conditions: Diseases of the circulatory system

Registration Number: KCT0003100

Lead Sponsor: Seoul National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 1700

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 prior to any study related procedure.
?Patients suspected with ischemic heart disease
?Patients with intermediate degree of stenosis (40-70% stenosis by visual estimation) eligible for stent implantation who need FFR or IVUS clinically for further evaluation
?Target vessel size > 2.5mm in visual estimation
?Target vessels are limited to proximal to mid LAD, proximal to distal LCX, and RCA proximal to the PL-PDA bifurcation

Exclusion Criteria

?The patient has 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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient-oriented composite outcome (POCO), defined as a composite of all death, myocardial infarction (MI) or any repeat revascularization at 24 months after randomization according to the ARC consensus

Secondary Outcome Measures

Name	Time	Method
POCO at 12months after randomization according to the ARC consensus;Stent-oriented composite endpoint (a composite of cardiac death, target-vessel MI, or target lesion revascularization);All-cause and cardiac death;Target-vessel and all-cause nonfatal MI without peri-procedural MI;Target-vessel and all-cause nonfatal MI with peri-procedural MI;arget vessel/lesion revascularization (ischemia-driven or all);Non-target vessel/lesion revascularization (ischemia-driven or all);Any revascularization (ischemia-driven or all);Stent thrombosis (definite/probable/possible);Stroke (ischemic and hemorrhagic);Acute success of procedure (device, lesion and procedure);Angina severity measured with Seattle Angina Questionnaires