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CompletedNCT06013007Updated Mar 9, 2026

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

An interventional study of ICI-guided JINS approach in Acute Coronary Syndrome and De Novo Stenosis, sponsored by Zunyi Medical College. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-03-09.

Sponsored by Zunyi Medical College · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
161
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed 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.

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Conditions studied

  • Acute Coronary Syndrome
  • De Novo Stenosis

Keywords

  • JINS; Intracoronary imaging; Stent optimization; Outcomes
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In context

Acute Coronary Syndrome

1,461 studies on the registry are indexed under Acute Coronary Syndrome; 267 are open to participants now.

This study's enrollment of 161 is below the median of 200 across 869 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Zunyi Medical College is the lead sponsor of 20 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
161 participants (actual)

Study arms

  • Experimental
    JINS approach

    The JINS approach is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.

    Procedure: ICI-guided JINS approach

Interventions

  • ProcedureICI-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).

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: At 24 hours

Secondary outcomes

  1. Target vessel failure

    Composite of cardiac death, target vessel myocardial infarction, ischaemia-driven target vessel revascularization.

    Time frame: At 12 months

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Study locations

1 site
  • Affiliated Hospital of Zunyi Medical University
    Zunyi, Guizhou 563003, China
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References and documents

Publications

  • 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. PubMed 22109977 ↗
  • 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. PubMed 24593834 ↗
  • 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. PubMed 28112479 ↗
  • 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. PubMed 29790954 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06013007
Lead sponsor
Zunyi Medical College
Responsible party
Cai De Jin, MD (Principal Investigator, Zunyi Medical College) — Principal investigator
First posted
Aug 28, 2023
Start date
Aug 22, 2023
Primary completion
Mar 5, 2026
Completion
Mar 5, 2026
Last update
Mar 9, 2026

Study contacts

Cai De Jin, MD
principal investigator · Zunyi Medical College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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