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Percutaneous coronary intervention for coronary bifurcation lesions represents one of the most challenging procedures in interventional cardiology because of lower angiographic success rate and increased risk of procedural complications. The study is designed to enroll 200 patients with acute or chronic coronary syndromes that meet the indications for intervention and with angiographic confirmed de novo Medina type 0,1,0 or 0,0,1 bifurcation lesion. In view of the potential risks of using DCB alone in the treatment of de novo bifurcation lesions, the following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). The primary endpoint was late lumen loss and major adverse cardiovascular events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yao technique | Experimental | The following 2 treatment strategies are available. (1) DCB combined with provisional DES implantation 1-2 mm distally to the lesion ostium whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the lesion ostium followed by DCB (DES+DCB strategy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-coated balloon combined with provisional drug-eluting stent implantation | Procedure | (1) DCB combined with provisional DES implantation 1-2 mm distally to the ostium lesion whenever this was required (DCB+pDES strategy). (2) DES implantation 1-2 mm distally to the ostium lesions followed by DCB treatment (DES+DCB strategy). |
| Measure | Description | Time Frame |
|---|---|---|
| late lumen loss | post-procedural minimum lumen diameter minus follow-up minimum lumen diameter. | 9 months follow-up |
| major adverse cardiovascular events | include cardiac death, non-fatal myocardial infarction, and target lesion revascularization. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yaojun Zhang, Dr | Contact | +86-13770668667 | 13770668667@139.com |
| Name | Affiliation | Role |
|---|---|---|
| Yaojun Zhang, Dr | Xuzhou Third People's Hospital | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31669112 | Background | Escarcega RO. What is the Optimal Technique for Ostial Left Anterior Descending Artery Lesions? Cardiovasc Revasc Med. 2019 Dec;20(12):1063-1064. doi: 10.1016/j.carrev.2019.10.003. Epub 2019 Oct 22. No abstract available. | |
| 21828393 | Background | Dishmon DA, Elhaddi A, Packard K, Gupta V, Fischell TA. High incidence of inaccurate stent placement in the treatment of coronary aorto-ostial disease. J Invasive Cardiol. 2011 Aug;23(8):322-6. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 12053499 | Background | Hildick-Smith DJ, Shapiro LM. Ostial left anterior descending coronary artery stent positioning: partial preinflation prevents stent oscillation and facilitates accurate deployment. J Interv Cardiol. 2001 Aug;14(4):439-42. doi: 10.1111/j.1540-8183.2001.tb00355.x. |
| 26603986 | Background | Cayli M, Elbasan Z, Gur M, Seker T, Ucar H, Kuloglu O, Sen O, Sahin DY, Kalkan GY. Modified flower petal technique in the treatment of Medina type 0,0,1 or 0,1,0 lesions. EuroIntervention. 2015 Nov;11(7):772-9. doi: 10.4244/EIJV11I7A154. |
| 20142194 | Background | Gutierrez-Chico JL, Villanueva-Benito I, Villanueva-Montoto L, Vazquez-Fernandez S, Kleinecke C, Gielen S, Iniguez-Romo A. Szabo technique versus conventional angiographic placement in bifurcations 010-001 of Medina and in aorto-ostial stenting: angiographic and procedural results. EuroIntervention. 2010 Feb;5(7):801-8. doi: 10.4244/eijv5i7a134. |
| 30019847 | Background | Chen GC, Lu XM, Song YM, Gyawail L, Geng ZH, Song MB, Qian DH, Zhang YP, Ni DC, He Y. A 3-year experience of a simple, novel technique for accurate ostial/non-ostial coronary stenting: The buddy balloon anchor stent technique. Catheter Cardiovasc Interv. 2018 Nov 15;92(6):1147-1152. doi: 10.1002/ccd.27667. Epub 2018 Jul 18. |
| 34010192 | Background | Yang ZK, Hu J, Ding FH, Ni JW, Zhang RY, Shen WF. One-year outcome of single-stent crossover versus accurate ostial stenting for isolated left anterior descending ostial stenosis. Coron Artery Dis. 2022 Jan 1;31(1):e67-e72. doi: 10.1097/MCA.0000000000001071. |
| 35600287 | Background | Elkhateeb O, Thambi S, Beydoun H, Bishop H, Quraishi A, Kidwai B, Title L. Long-term outcomes following ostial left anterior descending artery intervention with or without crossover to left-main. Am J Cardiovasc Dis. 2022 Apr 15;12(2):73-80. eCollection 2022. |
| 27245124 | Background | Vaquerizo B, Fernandez-Nofreiras E, Oategui I, Suarez de Lezo J, Rumoroso JR, Martin P, Routledge H, Tizon-Marcos H. Second-Generation Drug-Eluting Balloon for Ostial Side Branch Lesions (001-Bifurcations): Mid-Term Clinical and Angiographic Results. J Interv Cardiol. 2016 Jun;29(3):285-92. doi: 10.1111/joic.12292. |
| 35346908 | Background | Erdogan E, Li Z, Zhu YX, Tufaro V, Feng SL, Li Q, Liang L, Chang S, Bu LT, Liu B, Zhou QH, Yap NAL, Bourantas CV, Zhang YJ. DCB combined with provisional DES implantation in the treatment of De Novo Medina 0,1,0 or 0,0,1 left main coronary bifurcation lesions: A proof-of-concept study. Anatol J Cardiol. 2022 Mar;26(3):218-225. doi: 10.5152/AnatolJCardiol.2021.1157. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |