Bingo Drug-eluting Balloon in Bifurcation
Not Applicable
Completed
- Conditions
- Drug Eluting BalloonBifurcation Lesions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 222
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie the drug coating on the Bingo balloon for coronary bifurcation stenosis?
How does the Bingo drug-eluting balloon compare to standard stenting techniques in treating bifurcation lesions?
Which biomarkers correlate with improved outcomes in patients treated with Bingo drug-eluting balloon for coronary bifurcation disease?
What are the potential adverse events and management strategies for Bingo drug-eluting balloon in bifurcation stenosis trials?
Are there other drug-eluting balloons, like Sequent or AngioSculpt, used for bifurcation lesions and how do they compare to Bingo?
Trial Locations
- Locations (1)
General Hospital of Shenyang Military Region
🇨🇳Shenyang, Liaoning, China
General Hospital of Shenyang Military Region🇨🇳Shenyang, Liaoning, China