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| Name | Class |
|---|---|
| Shenzhen People's Hospital | OTHER |
| Kashgar 1st People's Hospital | OTHER |
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This study aims to test the hypothesis that jailed-balloon technique(JBT) is superior to jailed-wire technique(JWT) in non-left main coronary bifurcation percutaneous coronary intervention(PCI) by lowering the risk of side branch(SB) loss and PCI related myocardial infarction, as well as 1-year major adverse cardiovascular events(MACEs).
4a. Study populations: Patients with non-left main coronary bifurcation lesions(Medina 1,1,1 ), which SBs are less than 2.5mm and more than 1mm, are enrolled in this study. Patients are randomized to JBT group and JWT group.
4b. Procedure: For patients enrolled in JBT group, a monorail balloon is placed at the ostium of SB to protect the SB before the stent in main branch(MB) is deployed. Only a PTCA wire would be placed in the SB while stenting MB for patients randomized in JWT group. Only drug-eluting stent should be implanted in the target vessel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Jailed-balloon technique | Experimental | Apply jailed-balloon technique to protect the side branch during coronary bifurcation PCI |
|
| Jailed-wire technique | Active Comparator | Apply jailed-wire technique to protect the side branch during coronary bifurcation PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Jailed-balloon technique | Procedure | A monorail balloon is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to nominal pressure, the balloon in SB is inflated to 3 atm generally but to higher pressure to perform angioplasty if the blood flow in SB is compromised. The balloon in SB is then removed while the wire in SB is left in place. The MB stent balloon is inflated again for stent apposition. The SB wire is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the stent balloon is inflated again. |
| Measure | Description | Time Frame |
|---|---|---|
| Side branch(SB) loss and PCI related myocardial infarction | The primary outcome of the study is a composite of SB loss or PCI related myocardial infarction. According to Thrombolysis in Myocardial Infarction (TIMI) flow grading system, SB loss is defined as less than TIMI 3 flow immediately following MB stenting. It is considered temporary SB loss if TIMI 3 flow is restored with angioplasty and/or stenting. Otherwise, SB loss is considered permanent. In patients with normal (≤99th percentile URL) baseline cardiac troponin(cTn) concentrations, PCI related myocardial infarction is defined as elevations of cTn >5× 99th percentile URL occurring within 48 hours of the procedure, which should be accompanied with other evidence of myocardial injury. A rise of >20% is required for the diagnosis of PCI related myocardial infarction if the baseline cTn values are elevated and are stable or falling. | Within 48 hours after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Major adverse cardiovascular events(MACEs) | MACEs is a composite end point including cardiac death, non fatal myocardial infarction and target vessel revascularization(TVR). | Within 1 year after PCI |
| PCI related complication |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pengcheng He, Doctor | Contact | 86-20-83827812 | 10580 | he_peng_cheng@aliyun.com |
| Jianfang Luo, Doctor | Contact | 86-20-83827812 | 11300 | henyjfl@tom.com |
| Name | Affiliation | Role |
|---|---|---|
| Jiyan Chen, Doctor | Guangdong Provincial People's Hospital | Study Chair |
| Jianfang Luo, Doctor | Guangdong Provincial People's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen People's Hospital | Shenzhen | Guangdong | 518020 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19962049 | Background | Sharma SK, Sweeny J, Kini AS. Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001. | |
| 19463303 | Background | Latib A, Colombo A. Bifurcation disease: what do we know, what should we do? JACC Cardiovasc Interv. 2008 Jun;1(3):218-26. doi: 10.1016/j.jcin.2007.12.008. |
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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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|
| Jailed-wire technique | Procedure | A percutaneous transluminal coronary angioplasty(PTCA) wire is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to some pressure to achieve full apposition, the wire in SB is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the MB stent is deployed. |
|
PCI related complication include coronary dissection, coronary perforation, device dislodgement, device entrapment and device rupture.
| Immediately after PCI |
| Pengcheng He, Doctor |
| Guangdong Provincial People's Hospital |
| Principal Investigator |
| Kashgar District 1st People's Hospital | Kashgar | Xinjiang | 844000 | China |
|
| 23420654 | Background | Depta JP, Patel Y, Patel JS, Novak E, Yeung M, Zajarias A, Kurz HI, Lasala JM, Bach RG, Singh J. Long-term clinical outcomes with the use of a modified provisional jailed-balloon stenting technique for the treatment of nonleft main coronary bifurcation lesions. Catheter Cardiovasc Interv. 2013 Nov 1;82(5):E637-46. doi: 10.1002/ccd.24778. Epub 2013 Jul 30. |
| 20058502 | Background | Colombo F, Biondi-Zoccai G, Infantino V, Omede P, Moretti C, Sciuto F, Siliquini R, Chiado S, Trevi GP, Sheiban I. A long-term comparison of drug-eluting versus bare metal stents for the percutaneous treatment of coronary bifurcation lesions. Acta Cardiol. 2009 Oct;64(5):583-8. doi: 10.2143/AC.64.5.2042686. |
| 22364484 | Background | Singh J, Patel Y, Depta JP, Mathews SJ, Cyrus T, Zajarias A, Kurz HI, Lasala JM, Bach RG. A modified provisional stenting approach to coronary bifurcation lesions: clinical application of the "jailed-balloon technique". J Interv Cardiol. 2012 Jun;25(3):289-96. doi: 10.1111/j.1540-8183.2011.00716.x. Epub 2012 Feb 26. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |