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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-22

Study Completion Date

2025-09-22

Brief Summary

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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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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome De Novo Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Eligible patients will be implanted with DES by Joint Inflation with Nominal-pressure and Stability (JINS) approach, which is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JINS approach

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

Group Type EXPERIMENTAL

ICI-guided JINS approach

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No