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

NCT ID: NCT06441539

Last Updated: 2024-06-04

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-01
• Study Completion Date: 2026-05-31

Brief Summary

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

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

drug-eluting balloon

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

Group Type: EXPERIMENTAL

Bingo® Paclitaxel coated balloon

Intervention Type: DEVICE

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

drug-eluting stent

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

Group Type: ACTIVE_COMPARATOR

Xience® Alpine Everolimus Eluting Coronary Stent System

Intervention Type: DEVICE

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

Interventions

Bingo® Paclitaxel coated balloon

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

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

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)

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yinyi(Liaoning) Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

LNYY2024001

Identifier Type: -

Identifier Source: org_study_id