Clinical trial NCT06013007: Joint Inflation With Nominal-pressure and Stability Approach in DES Optimization
Official title: Joint Inflation With Nominal-pressure and Stability Approach in Coronary Drug-Eluting Stent Optimization and Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Coronary Syndrome
De Novo Stenosis
Keywords: JINS; Intracoronary imaging; Stent optimization; Outcomes
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2023-08-28
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stent optimization
timeFrame: At 24 hours
Secondary outcomes:
measure: Target vessel failure
timeFrame: At 12 months
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
Study officials:
affiliation: Zunyi Medical College
name: Cai De Jin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hovasse T, Mylotte D, Garot P, Salvatella N, Morice MC, Chevalier B, Pichard A, Lefevre T. Duration of balloon inflation for optimal stent deployment: five seconds is not enough. Catheter Cardiovasc Interv. 2013 Feb;81(3):446-53. doi: 10.1002/ccd.23343. Epub 2012 Jan 10.
citation: Ann SH, Chung JW, DE Jin C, Lee JH, Kim JM, Garg S, Shin ES. Better inflation time of stent balloon for second-generation drug-eluting stent expansion and apposition: an optical coherence tomography study. J Interv Cardiol. 2014 Apr;27(2):171-6. doi: 10.1111/joic.12096. Epub 2014 Mar 5.
citation: Vallurupalli S, Kasula S, Kumar Agarwal S, Pothineni NVK, Abualsuod A, Hakeem A, Ahmed Z, Uretsky BF. A novel stent inflation protocol improves long-term outcomes compared with rapid inflation/deflation deployment method. Catheter Cardiovasc Interv. 2017 Aug 1;90(2):233-240. doi: 10.1002/ccd.26930. Epub 2017 Jan 23.
citation: Raber L, Mintz GS, Koskinas KC, Johnson TW, Holm NR, Onuma Y, Radu MD, Joner M, Yu B, Jia H, Meneveau N, de la Torre Hernandez JM, Escaned J, Hill J, Prati F, Colombo A, di Mario C, Regar E, Capodanno D, Wijns W, Byrne RA, Guagliumi G; ESC Scientific Document Group. Clinical use of intracoronary imaging. Part 1: guidance and optimization of coronary interventions. An expert consensus document of the European Association of Percutaneous Cardiovascular Interventions. Eur Heart J. 2018 Sep 14;39(35):3281-3300. doi: 10.1093/eurheartj/ehy285.