Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions

Yinyi Biotech

Status: Not yet enrolling

Conditions: Coronary Artery Disease

Treatments: Device: Xience® Alpine Everolimus Eluting Coronary Stent System; Device: Bingo® Paclitaxel coated balloon

Study type: Interventional

Funder types: Industry

Identifiers

NCT06441539

LNYY2024001

Details and patient eligibility

About

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

Enrollment: 218 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

218 participants in 2 patient groups

drug-eluting balloon

Experimental group

Description:

Treat the main vessel and side branch of bifurcation lesion with drug-eluting balloon

Treatment:

Device: Bingo® Paclitaxel coated balloon

drug-eluting stent

Active Comparator group

Description:

Treat the main vessel of bifurcation lesion with drug-eluting stent, and treat the side branch with uncoated balloon or drug-eluting stent

Treatment:

Device: Xience® Alpine Everolimus Eluting Coronary Stent System