Acute Coronary Syndrome Clinical Trial
Official title:
Joint Inflation With Nominal-pressure and Stability Approach in Coronary Drug-Eluting Stent Optimization and Outcomes
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.
Status | Recruiting |
Enrollment | 130 |
Est. completion date | September 22, 2025 |
Est. primary completion date | August 22, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Patients with acute coronary syndrome (UA/NSTEMI/STEMI) plan to undergo OCT- or IVUS-guided DES implantation in de novo lesion. - Patients provide written informed consent prior to enrollment. Exclusion Criteria: - Left main, ostial right coronary artery lesion. - High thrombus burden at the index primary percutaneous coronary intervention. - Active bleeding or bleeding diathesis, thrombocytopenia (platelet <100,000/mL), or hemoglobin <10 g/dL - Hepatic dysfunction (serum liver enzyme>3 times the normal limit) - Renal failure (eGFR <15 ml/min/1.73m2 or requiring dialysis) - Life expectancy < 1 year |
Country | Name | City | State |
---|---|---|---|
China | Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou |
Lead Sponsor | Collaborator |
---|---|
Zunyi Medical College |
China,
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: 10.1 — View Citation
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. E — View Citation
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 Docu — View Citation
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | Target vessel failure | Composite of cardiac death, target vessel myocardial infarction, ischaemia-driven target vessel revascularization. | At 12 months |
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