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

NCT06013007 | Completed

• 1 other identifier: JINS
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; De Novo Stenosis

Keywords

JINS; Intracoronary imaging; Stent optimization; Outcomes

Outcome Measures

Primary Outcomes (1)

• 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.

  At 24 hours

Secondary Outcomes (1)

• Target vessel failure

  At 12 months

Study Arms (1)

JINS approach

EXPERIMENTAL

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

Interventions

ICI-guided JINS approach 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).

JINS approach

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zunyi Medical College: lead

Study Sites (1)

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, 563003, China

Location

Related Publications (4)

• 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.

  PMID: 22109977 RESULT

• 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.

  PMID: 24593834 RESULT

• 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.

  PMID: 28112479 RESULT

• 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.

  PMID: 29790954 RESULT

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Cai De Jin, MD

  Zunyi Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 28, 2023
• Study Start: August 22, 2023
• Primary Completion: March 5, 2026
• Study Completion: March 5, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CN (1)