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NCT Number: NCT06013007

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

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases De Novo Stenosis Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563003, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICI-guided JINS approach

Procedure

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).

Primary outcomes

  1. Stent optimization

    Time frame: At 24 hours

    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.

Secondary outcomes

  1. Target vessel failure

    Time frame: At 12 months

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

Sponsors and collaborators

Lead sponsor

Zunyi Medical College

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2023
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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