Bingo Drug-eluting Balloon in Bifurcation

Not Applicable

Completed

• Conditions: Drug Eluting Balloon; Bifurcation Lesions
• Interventions: Device: Uncoated ballloon; Device: Drug-eluting balloon

• Registration Number: NCT02325817
• Lead Sponsor: Yinyi(Liaoning) Biotech Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12-03
• Study First Submitted: 2014-12-20
• Study First Submitted QC: 2014-12-24
• Study First Posted: 2014-12-25
• Primary Completion: 2016-11-29
• Study Completion: 2017-01-13
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-23
• Last Update Posted: 2017-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 222

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Uncoated balloon	Uncoated ballloon	Treat the side branch of bifurcation lesion with uncoated balloon
Drug-eluting balloon	Drug-eluting balloon	Treat the side branch of bifurcation lesion with drug-eluting balloon

Primary Outcome Measures

Name	Time	Method
Target lesion Stenosis (diameter, %)	9 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital of Shenyang Military Region; 🇨🇳 Shenyang, Liaoning, China