UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056799 |
|---|---|
| Receipt number | R000064884 |
| Scientific Title | Investigation of the Impact of Radial Wall Strain at Coronary Stent Edges on Edge Restenosis After Percutaneous Coronary Intervention |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2025/01/23 16:23:23 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation of the Impact of Radial Wall Strain at Coronary Stent Edges on Edge Restenosis After Percutaneous Coronary Intervention
Acronym
Investigation of the Impact of Radial Wall Strain at Coronary Stent Edges on Edge Restenosis After Percutaneous Coronary Intervention
Scientific Title
Investigation of the Impact of Radial Wall Strain at Coronary Stent Edges on Edge Restenosis After Percutaneous Coronary Intervention
Scientific Title:Acronym
Investigation of the Impact of Radial Wall Strain at Coronary Stent Edges on Edge Restenosis After Percutaneous Coronary Intervention
Region
| Japan |
Condition
Condition
Coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to analyze the radial wall strain (RWS) in the vascular wall within 5 mm proximal and distal to the stent edges (illustrated schematically) as observed on coronary angiography (CAG) after stent implantation. The study focuses on patients with coronary artery disease who underwent percutaneous coronary intervention (PCI) using second-generation or later drug-eluting stents (DES). Furthermore, it aims to investigate the relationship between RWS at the stent edges and late stent-edge restenosis during the long-term follow-up period after stent implantation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
RWS values at stent edges on post-pci cag in stent edge restenotic and non-restenotic lesions
Key secondary outcomes
1) RWS values at stent edges on post-PCI CAG in clinical stent edge restenotic and non-restenotic lesions
2) RWS values at stent edges on pre-PCI CAG in stent edge restenotic and non-restenotic lesions
3) Target Lesion Revascularization (TLR)
4) Target Vessel Revascularization (TVR)
5) Culprit Lesion-Related Major Adverse Cardiac Events (CL-MACE)
6) Stent Edge-Related Major Adverse Cardiac Events (Stent Edge-Related MACE)
7) In-Stent Segment-Related Major Adverse Cardiac Events (In-Stent Segment-Related MACE)
8) Cardiac Death
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who underwent PCI using second-generation or later DES for untreated lesions
2) Patients who underwent follow-up CAG at least one month after PCI
3) Patients aged 20 years or older at the time of PCI
Key exclusion criteria
1) Lesions where RWS measurement is challenging
2) Proximal stent edges of lesions where DES is implanted in the coronary ostium
3) Lesions located in vessels that underwent bypass surgery
4) Lesions where DES is implanted in graft vessels
5) Lesions showing coronary dissection on the final angiography during PCI
6) Lesions located in small vessels with a diameter of 2 mm or less
7) Lesions showing more than 50% stenosis at stent edges on the final angiography during PCI
Target sample size
1300
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Takata |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
6500017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
hotake@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Takata |
Organization
Kobe University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
6500017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-5846
Homepage URL
forestwwood13@gmail.com
Sponsor or person
Institute
Kobe University Hospital
Institute
Department
Personal name
Ken Takata
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Ethics Committee of Kobe University Hospital
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe, Hyogo
Tel
078-382-5846
forestwwood13@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 03 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2025 | Year | 01 | Month | 23 | Day |
Last modified on
| 2025 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064884
