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

Not Applicable

Recruiting

• Conditions: Acute Coronary Syndrome; De Novo Stenosis
• Interventions: Procedure: ICI-guided JINS approach

• Registration Number: NCT06013007
• Lead Sponsor: Zunyi Medical College

Brief 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.

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 Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-21
• Study Start: 2023-08-22
• Study First Submitted QC: 2023-08-25
• Last Update Submitted: 2023-08-25
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28
• Primary Completion: 2025-08-22
• Study Completion: 2025-09-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Stent optimization	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 Outcome Measures

Name	Time	Method
Target vessel failure	At 12 months	Composite of cardiac death, target vessel myocardial infarction, ischaemia-driven target vessel revascularization.

Trial Locations

Locations (1)

Affiliated Hospital of Zunyi Medical University; 🇨🇳 Zunyi, Guizhou, China