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

Launched by YINYI(LIAONING) BIOTECH CO., LTD. · May 28, 2024

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Gender

ALL

Eligibility 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