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

Zunyi Medical College161 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

161

Conditions

Acute Coronary Syndrome De Novo Stenosis

Interventions

ICI-guided JINS approachPROCEDURE

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Outcomes

Primary Outcomes

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

Target vessel failure

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

Time frame: At 12 months

Data from ClinicalTrials.gov

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