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

March 5, 2026 updated by: Cai De Jin, MD, Zunyi Medical College

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

161

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guizhou
      • Zunyi, Guizhou, China, 563003
        • Affiliated Hospital of ZunYi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target vessel failure
Time Frame: At 12 months
Composite of cardiac death, target vessel myocardial infarction, ischaemia-driven target vessel revascularization.
At 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zunyi Medical College

Investigators

  • Principal Investigator: Cai De Jin, MD, Zunyi Medical College

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2023

Primary Completion (Actual)

March 5, 2026

Study Completion (Actual)

March 5, 2026

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 25, 2023

First Posted (Actual)

August 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JINS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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