Bingo Drug-eluting Balloon in Bifurcation

Yinyi Biotech

Status

Completed

Conditions

Drug Eluting Balloon

Bifurcation Lesions

Treatments

Device: Drug-eluting balloon

Device: Uncoated ballloon

Study type

Interventional

Funder types

Industry

Identifiers

NCT02325817

BEYOND

Details and patient eligibility

About

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.

Enrollment

222 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or non-pregnant female ages 18-80 years old
Patients with asymptomatic myocardial ischemia symptom, stable or unstable angina pectoris or old myocardial infarction
Patients with bifurcation lesions of coronary artery observed by angiography.
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.
De Novo bifurcation lesions and diameter stenosis are not less than70%;
Referenced vessel diameters range from 1.25mm to 5.0mm, and lesions range are not more than 40mm
Residual stenosis are not more than 50% after predilatation;
Patients who understand the purpose of this trial, voluntary and sign informed consent.

Exclusion criteria

Heavily calcified lesions which cannot be dalatated successfully, and the lesions which are not suitable by balloon angioplasty
Left main coronary artery lesions without protection or related bifurcation lesions
Patients with severe heart failure symptoms (above NYHA III) or Left ventricular ejection fraction (LVEF) below 35% (ultrasound or left ventricular angiography)
Impairment of the renal function preoperative: Serum creatinine above 2.0mg/dl；
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;
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)
Patients whose expected lives are less than 1 year;
Patients who are considered to have poor compliance and cannot complete the trial in accordance with requirements.
In-stent restenosis lesions
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.