Bingo Drug-eluting Balloon in Bifurcation

A Multicenter, Superior, Randomized Controlled Clinical Trial to Observe the Safety and Efficacy of Bingo Drug-eluting Balloon vs. Yinyi Balloon Dilatation Catheter in the Treatment of Patients With Bifurcation Stenosis Lesions of Coronary Artery

The purpose is to observe and evaluate the safety and efficacy of Bingo drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.

Study Overview

• Status: Completed
• Conditions: Bifurcation Lesions; Drug Eluting Balloon
• Intervention / Treatment: Device: Drug-eluting balloon; Device: Uncoated ballloon

• Study Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Liaoning
    • Shenyang, Liaoning, China, 110016
      • General Hospital of Shenyang Military Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or non-pregnant female ages 18-80 years old
2. Patients with asymptomatic myocardial ischemia symptom, stable or unstable angina pectoris or old myocardial infarction
3. Patients with bifurcation lesions of coronary artery observed by angiography.
4. The main branch of the vessels are suitable for PCI and stent therapy, and the side branch are intended to implement the kissing dilatation without considering dual stent implantation.
5. De Novo bifurcation lesions and diameter stenosis are not less than70%;
6. Referenced vessel diameters range from 1.25mm to 5.0mm, and lesions range are not more than 40mm
7. Residual stenosis are not more than 50% after predilatation;
8. Patients who understand the purpose of this trial, voluntary and sign informed consent.

Exclusion Criteria:

1. Heavily calcified lesions which cannot be dalatated successfully, and the lesions which are not suitable by balloon angioplasty
2. Left main coronary artery lesions without protection or related bifurcation lesions
3. Patients with severe heart failure symptoms (above NYHA III) or Left ventricular ejection fraction (LVEF) below 35% (ultrasound or left ventricular angiography)
4. Impairment of the renal function preoperative: Serum creatinine above 2.0mg/dl；
5. Patients with hemorrhagic tendency, the history of active digestive ulcers, the history of subarachnoid hemorrhage cerebral hemorrhage, antiplatelet and anticoagulant therapy contraindication and unable to anticoagulant therapy;
6. Patients who are allergic to aspirin, ticagrelor, clopidogrel, ticlopidine, heparin, contrast agent and paclitaxel, and cannot 1-year tolerate dual antiplatelet therapy (aspirin + clopidogrel or ticagrelor)
7. Patients whose expected lives are less than 1 year;
8. Patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements.
9. In-stent restenosis lesions
10. Patients who are enrolled in this trial and need stent therapy due to vascular laceration or severe stenosis, and those patients are calculated as fall off cases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Drug-eluting balloon; Treat the side branch of bifurcation lesion with drug-eluting balloon	Device: Drug-eluting balloon; Treat the side branch of bifurcation lesion with drug-eluting balloon
Active Comparator: Uncoated balloon; Treat the side branch of bifurcation lesion with uncoated balloon	Device: Uncoated ballloon; Treat the side branch of bifurcation lesion with uncoated balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target lesion Stenosis (diameter, %)	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TLR		1, 6 and 9 months
TVR		1, 6 and 9 months
TLF	cardiac death, target vessel MI, TLR	1, 6 and 9 months
MACCE	all-cause death, MI, stroke and TVR	1, 6 and 9 months
All-cause death		1, 6 and 9 months
Cardiac death		1, 6 and 9 months
Non-fatal MI, thrombosis		1, 6 and 9 months
Thrombosis		1, 6 and 9 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Jing QM, Zhao X, Han YL, Gao LL, Zheng Y, Li ZQ, Yang P, Cong HL, Gao CY, Jiang TM, Li H, Li JX, Wang DM, Wang G, Cong ZC, Zhang Z. A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China. Chin Med J (Engl). 2020 Apr 20;133(8):899-908. doi: 10.1097/CM9.0000000000000743.

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2014
• Primary Completion (Actual): November 29, 2016
• Study Completion (Actual): January 13, 2017

Study Registration Dates

• First Submitted: December 20, 2014
• First Submitted That Met QC Criteria: December 24, 2014
• First Posted (Estimate): December 25, 2014

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: paclitaxel; drug eluting balloon; drug coated balloon; Bifurcation Lesions
• Other Study ID Numbers: BEYOND (Company internal)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No