None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : Patients will be randomized to either the DCB group or the DES group with 1:1 ratio during the index procedure after diagnostic angiography. Stratified randomizati
2) =35% residual stenosis
3) TIMI (Thrombolysis In Myocardial Infarction) flow grade 3
and 4) the absence of a flow-limiting dissection. After successful lesion preparation, patients will receive either DCB or DES for coronary lesions according to randomly allocated groups.
In DCB grou
Agent, Boston Scientific, USA
Prevail, Medtronic, USA) will be used. DCB angioplasty will be recommended as follows to fully optimize procedural results.15,16 First, DCB size should be 1:1 ratio with reference vessel size. Second,
Sponsors
Samsung Medical Center
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 =2.25 mm 4. Patients with high bleeding risk: one or more of the criteria listed 1) Adjunctive oral anticoagulation treatment planned to continue after PCI 2) Age = 75 years old 3) Baseline Hemoglobin 30 days after PCI 9. Planned surgery that would require interruption of DAPT (within next 12 months) 10. Renal failure defined as calculated creatinine clearance <40 ml/min or on dialysis 11. Hematological disorders (platelet count <100,000/mm3 or any coagulation disorder) 12. Severe chronic liver disease defined as patients who have developed any of the following: variceal hemorrhage, ascites, hepatic encephalopathy or jaundice 13. Expected non-compliance to prolonged DAPT for other medical reasons
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 |
|---|---|
| Target vessel failure (a composite of cardiovascular death, target-vessel myocardial infarction [MI], and clinically indicated target-vessel revascularization [TVR]) | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular death ;All-cause death;Target-vessel MI ;Non-fatal MI ;Clinically indicated target-lesion revascularization;Clinically indicated target-vessel revascularization;Any revascularization;Vessel or stent thrombosis, definite or probable by Academic Research Consortium [ARC] definition;Cardiovascular death or target-vessel MI ;All-cause death or non-fatal MI ;Target lesion failure (TLF, a composite of cardiovascular death, target-vessel MI, and clinically indicated TLR) ;Cardiovascular death, target-vessel MI, or vessel or stent thrombosis ;All-cause death, non-fatal MI, or TVR ;Major bleeding (BARC type 2, 3 or 5 bleeding) ;Major bleeding (TIMI bleeding classification) | — |
Countries
Korea, Republic of
Contacts
Public ContactJoo Myung Lee
Samsung Medical Center
Outcome results
None listed