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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug-eluting balloon | Experimental | Treat the side branch of bifurcation lesion with drug-eluting balloon |
|
| Uncoated balloon | Active Comparator | Treat the side branch of bifurcation lesion with uncoated balloon |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-eluting balloon | Device | Treat the side branch of bifurcation lesion with drug-eluting balloon |
|
| Measure | Description | Time Frame |
|---|---|---|
| Target lesion Stenosis (diameter, %) | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| TLR | 1, 6 and 9 months | |
| TVR | 1, 6 and 9 months | |
| TLF |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Shenyang Military Region | Shenyang | Liaoning | 110016 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32265425 | Derived | 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. |
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| Uncoated ballloon | Device | Treat the side branch of bifurcation lesion with uncoated balloon |
|
cardiac death, target vessel MI, TLR
| 1, 6 and 9 months |
| MACCE | all-cause death, MI, stroke and TVR | 1, 6 and 9 months |
| All-cause death | 1, 6 and 9 months |
| Cardiac death | 1, 6 and 9 months |
| Non-fatal MI, thrombosis | 1, 6 and 9 months |
| Thrombosis | 1, 6 and 9 months |