Joint Inflation With Nominal-pressure and Stability Approach in DES Optimization

Acute Coronary Syndrome Clinical Trial

Official title:

Joint Inflation With Nominal-pressure and Stability Approach in Coronary Drug-Eluting Stent Optimization and Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06013007
• Other study ID #: JINS
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2023
• Est. completion date: September 22, 2025

Study information

• Verified date: August 2023
• Source: Zunyi Medical College
• Contact: Cai De Jin, MD
• Phone: 86+178-0250-2582
• Email: jincaide[@]zmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• De Novo Stenosis

Intervention

Procedure:
• ICI-guided JINS approach
OCT- or IVUS-guided JINS approach in DES implantation (DES types including Healing-Targeted SUPREME/Infinity Sirolimus-Eluting Stent, GuReater™ Sirolimus-Eluting Stent, XIENCE Alpine Everolimus-Eluting Stent, Promus PREMIER™ Everolimus-Eluting Stent, Resolute Integrity™ Zotarolimus-Eluting Stent, Firebird 2™ Sirolimus-Eluting Stent, Firekingfisher™ Sirolimus-Eluting Stent).

Locations

Country	Name	City	State
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Zunyi Medical College

Country where clinical trial is conducted

China, 

References & Publications (4)

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

Outcome

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