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To achieve the stent optimization following "Keep It Simple and Safe" coronary intervention is recommended. A protocol of Joint Inflation with Nominal-pressure and Stability (JINS) approach in coronary drug-eluting stent (DES) implantation by intracoronary imaging (ICI) guidance could provide additional benefits in reducing unnecessary radiation exposure, and post-dilatation balloon angioplasty-related complications.
Variable types of stent inflation protocol to achieve evidence and consensus-based coronary drug-eluting stent (DES) optimization could improve clinical outcomes. The investigators aim to evaluate whether the JINS approach could be adopted in Chinese daily practice.
The investigators will perform ICI (OCT or IVUS)-guided DES implantation in coronary de novo lesions by JINS protocol, described as inflating stent balloon with nominal-pressure (+1~2atm) without decay for at least 30 seconds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JINS approach | Experimental | The JINS approach is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICI-guided JINS approach | Procedure | OCT- or IVUS-guided JINS approach in DES implantation (DES types including Healing-Targeted SUPREME/Infinity Sirolimus-Eluting Stent, GuReaterâ„¢ Sirolimus-Eluting Stent, XIENCE Alpine Everolimus-Eluting Stent, Promus PREMIERâ„¢ Everolimus-Eluting Stent, Resolute Integrityâ„¢ Zotarolimus-Eluting Stent, Firebird 2â„¢ Sirolimus-Eluting Stent, Firekingfisherâ„¢ Sirolimus-Eluting Stent). |
| Measure | Description | Time Frame |
|---|---|---|
| Stent optimization | To achieve the targets as follow: minimal stent area (MSA) >5.5 mm2 by IVUS or MSA >4.5mm2 by OCT, stent expansion >80% (MSA divided by average reference lumen area), no significant malapposition, no significant stent edge dissection, no significant tissue protrusion, and successful DES implantation without the occurrence of cardiac death, target vessel myocardial infarction, target lesion revascularization, acute stent thrombosis during the first 24 hours after an index procedure. | At 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Target vessel failure | Composite of cardiac death, target vessel myocardial infarction, ischaemia-driven target vessel revascularization. | At 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cai De Jin, MD | Zunyi Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou | 563003 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22109977 | Result | Hovasse T, Mylotte D, Garot P, Salvatella N, Morice MC, Chevalier B, Pichard A, Lefevre T. Duration of balloon inflation for optimal stent deployment: five seconds is not enough. Catheter Cardiovasc Interv. 2013 Feb;81(3):446-53. doi: 10.1002/ccd.23343. Epub 2012 Jan 10. | |
| 24593834 | Result | Ann SH, Chung JW, DE Jin C, Lee JH, Kim JM, Garg S, Shin ES. Better inflation time of stent balloon for second-generation drug-eluting stent expansion and apposition: an optical coherence tomography study. J Interv Cardiol. 2014 Apr;27(2):171-6. doi: 10.1111/joic.12096. Epub 2014 Mar 5. |
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| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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Eligible patients will be implanted with DES by Joint Inflation with Nominal-pressure and Stability (JINS) approach, which is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.
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| 28112479 | Result | Vallurupalli S, Kasula S, Kumar Agarwal S, Pothineni NVK, Abualsuod A, Hakeem A, Ahmed Z, Uretsky BF. A novel stent inflation protocol improves long-term outcomes compared with rapid inflation/deflation deployment method. Catheter Cardiovasc Interv. 2017 Aug 1;90(2):233-240. doi: 10.1002/ccd.26930. Epub 2017 Jan 23. |
| 29790954 | Result | Raber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, Radu MD, Joner M, Yu B, Jia H, Meneveau N, de la Torre Hernandez JM, Escaned J, Hill J, Prati F, Colombo A, di Mario C, Regar E, Capodanno D, Wijns W, Byrne RA, Guagliumi G; ESC Scientific Document Group. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018 Sep 14;39(35):3281-3300. doi: 10.1093/eurheartj/ehy285. |