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

Not Applicable

Not yet recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: Xience® Alpine Everolimus Eluting Coronary Stent System; Device: Bingo® Paclitaxel coated balloon

• Registration Number: NCT06441539
• Lead Sponsor: Yinyi(Liaoning) Biotech Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-05
• Study First Submitted: 2024-05-22
• Study First Submitted QC: 2024-05-28
• Last Update Submitted: 2024-05-28
• Study First Posted: 2024-06-04
• Last Update Posted: 2024-06-04
• Study Start: 2024-07-01
• Primary Completion: 2025-02-28
• Study Completion: 2026-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 218

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
drug-eluting stent	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
drug-eluting balloon	Bingo® Paclitaxel coated balloon	Treat the main vessel and side branch of bifurcation lesion with drug-eluting balloon

Primary Outcome Measures

Name	Time	Method
in-segment late lumen loss in main branch	9 months	use quantitative coronary angiography by an independent core laboratory

Secondary Outcome Measures

Name	Time	Method
Procedure success rates	up to 7 days in-hospital	include device success, lesion success and clinical success
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
Minimal lumen diameter	9 months	use quantitative coronary angiography by an independent core laboratory
Stroke	1, 6, 9 and 12 months	any stroke
Diameter stenosis	9 months	use quantitative coronary angiography by an independent core laboratory
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
Target lesion failure	1, 6, 9 and 12 months	include cardiac death, target vessel myocardial infarction, clinically driven target lesion revascularization
Target lesion thrombosis	1, 6, 9 and 12 months	include acute, sub-acute, late and very late period
BARC bleeds	1, 6, 9 and 12 months	type 2, 3 or 5
Major Adverse Cardiovascular Events	1, 6, 9 and 12 months	composite endpoint with death, myocardial infarction and target vessel revascularization