None listed
Conditions
Interventions
Procedure/Surgery : 1) Provisional 1-stent plus DEB strategy
As a principal, the treatment regime will be composed of the stent treatment in the main blood vessel and a drug-eluting balloon in a branc
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? 19+ years old ? Patients with the following lesions and clinical factors. 2-1. The lesion factor: Visually confirmed diameter of the 2.25-2.75 mm in branched vessels, where the main blood vessel’s diameter is at least 2.5 mm; the lesion at the branched vessels is of a Medina classification (1,1,1), (1,0,1), or (0,1,1), with a true bifurcation; a de novo lesion. 2-2 Clinical factors: Stable angina, unstable angina, ST segment elevated myocardial infarction, non-ST segment elevated myocardial infarction - ST segment elevated myocardial infarction patients with non-infarct related artery. ? Patients who understood the definitions of the test group and the control group and the risks involved in the treatment, and with voluntary, informed consent to participate in the study, as provided either by the patient or their legal representatives.
Exclusion criteria
Exclusion criteria: ? patients with an LM coronary true-bifurcation lesion. ? Patients who are ruled out by the treatment provider because the 2-stent strategy was deemed unsuitable to the patient due to a clinical condition. ? A patient with aspirin or P2Y12 inhibitors (ticagrelor or clopidogrel) contraindications. ? A patient who experienced psychogenic shock at the time of admission, or showed severe left ventricle insufficiency (where the left ventricle ejection fraction is less than 30%.) ? A patient who requires prolonged anti-coagulative treatment (warfarin or a new oral anti-coagulant [NOAC]) ? A patient who is currently hemorrhagic, or has a high risk of major hemorrhage (active peptic ulcer, GI lesions with high hemorrhagic risks, malicious tumors with a high risk of hemorrhage) ? A patient with a history of intra-cerebral hemorrhage or intra-cerebral aneurysm. ? A patient for whom surgery that requires antiplatelet treatment intervention is scheduled within the next six months. ? A patient with severe hepatic diseases (abdominal effusion) Platelet count at less than 80,000 cells/mm3 Hgb count at less than 10 g/dL ? A patient who appears to be at risk of bradycardia (a patient with an insufficiency of the said function, or a patient without a permanent pacemaker despite a grade 2 or higher atrioventricular block). ? A patient who tested positive in a pregnancy test, or is currently breastfeeding ? A patient with less than one year of remaining life expectancy due to comorbidity (based on the medical judgment of the investigator). ? A patient who is already participating in another randomized clinical study for other medicines or medical devices, where the primary end point has not been reached. ? A patient who did not sign her informed consent form, or could not be traced in the long-term.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target lesion failure (composite outcome of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) | — |
Secondary
| Measure | Time frame |
|---|---|
| ?All-cause death and cardiac death ?All-cause myocardial infarction, including peri-procedural MI ?Any revascularization (ischemia-driven or all) ?Target/non-target lesion revascularization ?Target/non-target vessel revascularization ?Stent thrombosis (definite/probable/possible) A. Target-lesion-related B. Non-target-lesion-related ?Cerebral infarction (ischemic or hemorrhagic) ?Compound events A. All-cause death, all MI, or all revascularization B. All cardiac death, target vessel MI, cerebral infarction, or clinically significant hemorrhage (BARC type 2, 3, 4, or 5) C. All cardiac death, target vessel MI, cerebral infarction, clinically necessary target vessel revascularization, or clinically significant hemorrhage (BARC type 2, 3, 4, or 5) ?The success rate of the procedure (device, lesion, and procedure) ?Efficiency of the Procedure A. Total procedure duration B. Total radiation dose C. Total contrast agent dose ?The occurrence rate of renal disorders caused by contrast agents (defined as an increase in serum creatinine of =0.5 mg/dL or =25% from the baseline within 48-72 hours after contrast agent exposure) | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-HO Her
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed