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Clinical Trials/NCT06441539
NCT06441539
Not yet recruiting
Not Applicable

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

Yinyi(Liaoning) Biotech Co., Ltd.0 sites218 target enrollmentJuly 1, 2024
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ConditionsCoronary Artery Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
Yinyi(Liaoning) Biotech Co., Ltd.
Enrollment
218
Primary Endpoint
in-segment late lumen loss in main branch
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
July 1, 2024
End Date
May 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •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
  • •Angiographic Inclusion Criteria (by visual):
  • •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

Exclusion Criteria

  • •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

Outcomes

Primary Outcomes

in-segment late lumen loss in main branch

Time Frame: 9 months

use quantitative coronary angiography by an independent core laboratory

Secondary Outcomes

  • Procedure success rates(up to 7 days in-hospital)
  • Dissection and type(9 months)
  • in-segment late lumen loss in side branch(9 months)
  • Binary restenosis(9 months)
  • Minimal lumen diameter(9 months)
  • Stroke(1, 6, 9 and 12 months)
  • Diameter stenosis(9 months)
  • Target lesion failure(1, 6, 9 and 12 months)
  • Target lesion thrombosis(1, 6, 9 and 12 months)
  • BARC bleeds(1, 6, 9 and 12 months)
  • Myocardial infarction(Peri-operation and 12 months)
  • Death(1, 6, 9 and 12 months)
  • Major Adverse Cardiovascular Events(1, 6, 9 and 12 months)

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