Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
222 participants
INTERVENTIONAL
2014-12-03
2017-01-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Drug-eluting balloon
Treat the side branch of bifurcation lesion with drug-eluting balloon
Drug-eluting balloon
Treat the side branch of bifurcation lesion with drug-eluting balloon
Uncoated balloon
Treat the side branch of bifurcation lesion with uncoated balloon
Uncoated ballloon
Treat the side branch of bifurcation lesion with uncoated balloon
Interventions
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Drug-eluting balloon
Treat the side branch of bifurcation lesion with drug-eluting balloon
Uncoated ballloon
Treat the side branch of bifurcation lesion with uncoated balloon
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
80 Years
ALL
No
Sponsors
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Yinyi(Liaoning) Biotech Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Countries
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References
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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.
Other Identifiers
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BEYOND
Identifier Type: -
Identifier Source: org_study_id
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