Clinical trial NCT06441539: Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions
Official title: Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions: a Prospective, Multi-center, Randomized, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Keywords: Coronary bifurcation
Percutaneous coronary intervention
Drug-coated balloon
Lead sponsor: Yinyi(Liaoning) Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-06-04
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bingo drug-eluting balloon versus a drug-eluting stent for coronary bifurcation lesions: a prospective, multi-center, randomized, non-inferiority trial


Eligibility 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 Exclusion Criteria (by visual):

1. In-stent restenosis lesion
2. Left main bifurcation lesion
3. Chronic total occlusive lesion
4. Target vessel is severely distorted, angulated or calcified, which is anticipated difficult to cross for balloon or stent
5. Target lesion remains significant residual thrombus after preparation

Primary outcomes:
measure: in-segment late lumen loss in main branch
timeFrame: 9 months
Secondary outcomes:
measure: Procedure success rates
timeFrame: up to 7 days in-hospital
measure: Minimal lumen diameter
timeFrame: 9 months
measure: Diameter stenosis
timeFrame: 9 months
measure: Dissection and type
timeFrame: 9 months
measure: in-segment late lumen loss in side branch
timeFrame: 9 months
measure: Binary restenosis
timeFrame: 9 months
measure: Target lesion failure
timeFrame: 1, 6, 9 and 12 months
measure: Target lesion thrombosis
timeFrame: 1, 6, 9 and 12 months
measure: BARC bleeds
timeFrame: 1, 6, 9 and 12 months
measure: Stroke
timeFrame: 1, 6, 9 and 12 months
measure: Myocardial infarction
timeFrame: Peri-operation and 12 months
measure: Death
timeFrame: 1, 6, 9 and 12 months
measure: Major Adverse Cardiovascular Events
timeFrame: 1, 6, 9 and 12 months
Other outcomes:
Locations:
Study officials:
References: