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

Coronary Artery Disease Clinical Trial

Official title:

Bingo Drug-eluting Balloon Versus a Drug-eluting Stent for Coronary Bifurcation Lesions: a Prospective, Multi-center, Randomized, Non-inferiority Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06441539
• Other study ID #: LNYY2024001
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: May 31, 2026

Study information

• Verified date: May 2024
• Source: Yinyi(Liaoning) Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 218
• Est. completion date: May 31, 2026
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Bingo® Paclitaxel coated balloon
Treat the main vessel and side branch of bifurcation lesion with drug-eluting balloon
• Xience® 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yinyi(Liaoning) Biotech Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	in-segment late lumen loss in main branch	use quantitative coronary angiography by an independent core laboratory	9 months
Secondary	Procedure success rates	include device success, lesion success and clinical success	up to 7 days in-hospital
Secondary	Minimal lumen diameter	use quantitative coronary angiography by an independent core laboratory	9 months
Secondary	Diameter stenosis	use quantitative coronary angiography by an independent core laboratory	9 months
Secondary	Dissection and type	use quantitative coronary angiography by an independent core laboratory	9 months
Secondary	in-segment late lumen loss in side branch	use quantitative coronary angiography by an independent core laboratory	9 months
Secondary	Binary restenosis	use quantitative coronary angiography by an independent core laboratory	9 months
Secondary	Target lesion failure	include cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization	1, 6, 9 and 12 months
Secondary	Target lesion thrombosis	include acute, sub-acute, late and very late period	1, 6, 9 and 12 months
Secondary	BARC bleeds	type 2, 3 or 5	1, 6, 9 and 12 months
Secondary	Stroke	any stroke	1, 6, 9 and 12 months
Secondary	Myocardial infarction	include peri-operation and 12 months	Peri-operation and 12 months
Secondary	Death	include cardiac and all-cause death	1, 6, 9 and 12 months
Secondary	Major Adverse Cardiovascular Events	composite endpoint with death, myocardial infarction and target vessel revascularization	1, 6, 9 and 12 months