Coronary Artery Disease
Conditions
Keywords
Coronary bifurcation, Percutaneous coronary intervention, Drug-coated balloon
Brief summary
Bingo drug-eluting balloon versus a drug-eluting stent for coronary bifurcation lesions: a prospective, multi-center, randomized, non-inferiority trial
Interventions
DEVICEBingo® Paclitaxel coated balloon
Treat the main vessel and side branch of bifurcation lesion with drug-eluting balloon
DEVICEXience® Alpine Everolimus Eluting Coronary Stent System
Treat the main vessel of bifurcation lesion with drug-eluting stent, and treat the side branch with uncoated balloon or drug-eluting stent
Sponsors
Yinyi(Liaoning) Biotech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Clinical Inclusion Criteria: 1. Age 18 to 80 2. Patients with chronic stable coronary artery disease, or unstable angina, or NSTEMI (Grace score\<140), or STEMI more than one week 3. Subjects suitable for PCI 4. Subjects understand the trial purpose, volunteer to participate and sign informed consent form Angiographic Inclusion Criteria (by visual): 1. One coronary de novo bifurcation lesion (including Medina classification: 1,1,1 / 1,0,1 / 0,1,1, which need to be treated for both main and side branches) 2. The reference vessel diameter of main branch is between 2.5 to 4.0 mm, length ≤ 30 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70%, or ≥50% with evidence of myocardial ischemia 3. The reference vessel diameter of side branch is ≥2.0 mm, length \<20 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70% 4. No more than 3 lesions on the non-target vessel in the same operation, and shall be successfully treated before the target vessel 5. No more than 1 non-target lesion on the target vessel in the same operation, and shall be successfully prepared before the target lesion (successful preparation of non-target lesion is defined as residual stenosis ≤30% and TIMI flow 3). After randomization, the non-target lesion shall be treated according to the assigned group, for the experimental group, using the experimental DCB is recommended; for the control group, using DES is recommended; Independent lesion on the same coronary artery is defined as interval \>5 mm 6. The target lesions of main and side branches must be successfully prepared (successful preparation is defined as: residual stenosis ≤30% , without NHLBI type C or above dissection, and TIMI flow 3) Clinical
Exclusion criteria
1. Severe heart failure (NYHA IV), cardiogenic shock or severe valvular heart disease 2. Left ventricular ejection fraction ≤35% 3. Severe renal insufficiency (eGFR \<30 ml/min) 4. Severe liver insufficiency (glutamate transaminase (ALT) or glutamate transaminase (AST) \>3 times the upper limit of normal) 5. Pregnant women or planned pregnancy 6. With a known allergy to heparin, contrast agent, paclitaxel and everolimus 7. Unable to receive antiplatelet agents and anticoagulants, bleeding tendency or coagulopathy 8. Life expectancy does not exceed 1 year 9. Participating in other drug or device clinical trials without reaching the primary endpoint 10. Subjects who had undergone coronary revascularization in the last 6 months 11. Subjects not eligible by the investigator for other reasons Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| in-segment late lumen loss in main branch | 9 months | use quantitative coronary angiography by an independent core laboratory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimal lumen diameter | 9 months | use quantitative coronary angiography by an independent core laboratory |
| Diameter stenosis | 9 months | use quantitative coronary angiography by an independent core laboratory |
| Dissection and type | 9 months | use quantitative coronary angiography by an independent core laboratory |
| in-segment late lumen loss in side branch | 9 months | use quantitative coronary angiography by an independent core laboratory |
| Binary restenosis | 9 months | use quantitative coronary angiography by an independent core laboratory |
| Target lesion failure | 1, 6, 9 and 12 months | include cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization |
| Procedure success rates | up to 7 days in-hospital | include device success, lesion success and clinical success |
| BARC bleeds | 1, 6, 9 and 12 months | type 2, 3 or 5 |
| Stroke | 1, 6, 9 and 12 months | any stroke |
| Myocardial infarction | Peri-operation and 12 months | include peri-operation and 12 months |
| Death | 1, 6, 9 and 12 months | include cardiac and all-cause death |
| Major Adverse Cardiovascular Events | 1, 6, 9 and 12 months | composite endpoint with death, myocardial infarction and target vessel revascularization |
| Target lesion thrombosis | 1, 6, 9 and 12 months | include acute, sub-acute, late and very late period |
Outcome results
None listed