Drug-eluting Balloon vs. Regular Balloon Dilatation in the Treatment of Patients With Bifurcation Lesions
This trial is active, not recruiting.
|Conditions||bifurcation lesions, coronary artery|
|Sponsor||Liaoning Biomedical Materials R&D Center Co., Ltd.|
|Start date||December 2014|
|End date||December 2015|
|Trial identifier||NCT02325817, Bifurcation|
The purpose is to observe and evaluate the safety and efficacy of drug-eluting balloon in the treatment of patients with bifurcation lesions of coronary artery.
Note: the drug-eluting balloons are manufactured and supported by Liaoning Biomedical Materials R&D Center Co., Ltd. (LBC).
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
Target lesion Stenosis (diameter, %)
time frame: 270-day
Male or female participants from 18 years up to 80 years old.
- 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.
- 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.
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