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

NCT06441539 | Not Yet Recruiting

• 1 other identifier: LNYY2024001
• Study Type: interventional
• Target: 218
• Locations: 0 countries
• Sites: N/A

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

Keywords

Coronary bifurcation; Percutaneous coronary intervention; Drug-coated balloon

Outcome Measures

Primary Outcomes (1)

• in-segment late lumen loss in main branch

  use quantitative coronary angiography by an independent core laboratory

  9 months

Secondary Outcomes (13)

• Procedure success rates

  up to 7 days in-hospital

• Minimal lumen diameter

  9 months

• Diameter stenosis

  9 months

• Dissection and type

  9 months

• in-segment late lumen loss in side branch

  9 months

Study Arms (2)

drug-eluting balloon

EXPERIMENTAL

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

Device: Bingo® Paclitaxel coated balloon

drug-eluting stent

ACTIVE COMPARATOR

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

Device: Xience® Alpine Everolimus Eluting Coronary Stent System

Interventions

Bingo® Paclitaxel coated balloon DEVICE

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

drug-eluting balloon

Xience® Alpine Everolimus Eluting Coronary Stent System DEVICE

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 stent

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 80
• Patients with chronic stable coronary artery disease, or unstable angina, or NSTEMI (Grace score\<140), or STEMI more than one week
• Subjects suitable for PCI
• Subjects understand the trial purpose, volunteer to participate and sign informed consent form
• 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)
• 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
• The reference vessel diameter of side branch is ≥2.0 mm, length \<20 mm. Before lesion preparation, lesion diameter stenosis shall be ≥70%
• No more than 3 lesions on the non-target vessel in the same operation, and shall be successfully treated before the target vessel
• 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
• 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)

You may not qualify if:

• Severe heart failure (NYHA IV), cardiogenic shock or severe valvular heart disease
• Left ventricular ejection fraction ≤35%
• Severe renal insufficiency (eGFR \<30 ml/min)
• Severe liver insufficiency (glutamate transaminase (ALT) or glutamate transaminase (AST) \>3 times the upper limit of normal)
• Pregnant women or planned pregnancy
• With a known allergy to heparin, contrast agent, paclitaxel and everolimus
• Unable to receive antiplatelet agents and anticoagulants, bleeding tendency or coagulopathy
• Life expectancy does not exceed 1 year
• Participating in other drug or device clinical trials without reaching the primary endpoint
• Subjects who had undergone coronary revascularization in the last 6 months
• Subjects not eligible by the investigator for other reasons
• In-stent restenosis lesion
• Left main bifurcation lesion
• Chronic total occlusive lesion
• Target vessel is severely distorted, angulated or calcified, which is anticipated difficult to cross for balloon or stent

Sponsors & Collaborators

• Yinyi(Liaoning) Biotech Co., Ltd.: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: June 4, 2024
• Study Start: July 1, 2024
• Primary Completion: February 28, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-05