None listed
Conditions
Interventions
Medical Device : Patients who are planning percutaneous coronary intervention will be screened based on the inclusion and exclusion criteria to determine eligibility. Patients will be randomized to ei
Sponsors
Chonnam National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject must be at least 19 years of age 2) Subject who is able to understand risks, benefits and treatment alternatives and sign informed consent voluntarily 3) Patients with at least one lesion with greater than 50% diameter stenosis or fractional flow reserve =0.80 requiring revascularization in de novo coronary artery of reference vessel size =3.0 mm
Exclusion criteria
Exclusion criteria: 1) Patients unable to provide consent 2) Patients with known intolerance to aspirin, P2Y12 inhibitors, or components of drug-eluting stents 3) Patients with angiographic findings of 1) Left main coronary artery disease 2) In-stent restenosis is the cause of target lesion 3) Target lesion in bypass graft 4) True bifurcation lesion that requires upfront 2-stenting 4) Patients who have non-cardiac co-morbid conditions with life expectancy <1 year 5) Patients who may result in protocol non-compliance (site investigator’s medical judgment) 6) Patients with cardiogenic shock or cardiac arrest 7) Patients with severe left ventricular systolic dysfunction (ejection fraction <30%) 8) Patients with severe valvular heart disease requiring open heart surgery 9) Pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Late-lumen loss | — |
Secondary
| Measure | Time frame |
|---|---|
| Minimal lumen diameter in quantitative coronary angiography;% diameter stenosis in quantitative coronary angiography;Minimal lumen diameter in intravascular ultrasound;Cardiovascular death;All-cause death;Rate of target vessel-MI;Rate of non-fatal MI;Rate of target lesion revascularization;Rate of target vessel revascularization;Rate of any revascularization;Rate of vessel or stent thrombosis;Cardiovascular death or target vessel-related myocardial infarction;All-cause death or non-fatal MI;Target vessel failure;Target lesion failure;Cardiovascular death, target-vessel MI, or vessel or stent thrombosis;All-cause death, non-fatal myocardial infarction, or target vessel revascularization;BARC type 2, 3, or 5 bleeding;Cerebrovascular accident | — |
Countries
Korea, Republic of
Contacts
Public ContactSeung Hun Lee
Chonnam National University Hospital
Outcome results
None listed