Back to resultsJoint Inflation With Nominal-pressure and Stability Approach in DES Optimization
Primary Purpose
Acute Coronary Syndrome, De Novo Stenosis
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ICI-guided JINS approach
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring JINS; Intracoronary imaging; Stent optimization; Outcomes
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
Sites / Locations
- Affiliated Hospital of Zunyi Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
JINS approach
Arm Description
The JINS approach is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Target vessel failure
Composite of cardiac death, target vessel myocardial infarction, ischaemia-driven target vessel revascularization.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06013007
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2023 (Actual)
Primary Completion Date
August 22, 2025 (Anticipated)
Study Completion Date
September 22, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zunyi Medical College
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, De Novo Stenosis
Keywords
JINS; Intracoronary imaging; Stent optimization; Outcomes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
JINS approach
Arm Type
Experimental
Arm Description
The JINS approach is described as inflating a stent balloon with nominal-pressure without decay for at least 30 seconds.
Intervention Type
Procedure
Intervention Name(s)
ICI-guided JINS approach
Intervention Description
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).
Primary Outcome Measure Information:
Title
Stent optimization
Description
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 Outcome Measure Information:
Title
Target vessel failure
Description
Composite of cardiac death, target vessel myocardial infarction, ischaemia-driven target vessel revascularization.
Time Frame
At 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cai De Jin, MD
Phone
86+178-0250-2582
Email
jincaide@zmu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Yan Jin, MD
Phone
86+157-7229-0925
Email
jinyanyan850925@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cai De Jin, MD
Organizational Affiliation
Zunyi Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Zunyi Medical University
City
Zunyi
State/Province
Guizhou
ZIP/Postal Code
563003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cai De Jin, MD
Phone
86+178-0250-2582
Email
jincaide@zmu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yan Yan Jin, MD
Phone
86+157-7229-0925
Email
jinyanyan850925@163.com
First Name & Middle Initial & Last Name & Degree
Cai De Jin, MD
12. IPD Sharing Statement
Citations:
PubMed Identifier
22109977
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.
Results Reference
result
PubMed Identifier
24593834
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.
Results Reference
result
PubMed Identifier
28112479
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.
Results Reference
result
PubMed Identifier
29790954
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. Erratum In: Eur Heart J. 2019 Jan 14;40(3):308.
Results Reference
result
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Joint Inflation With Nominal-pressure and Stability Approach in DES Optimization
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