UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031963 |
|---|---|
| Receipt number | R000035588 |
| Scientific Title | How does POst-PCI FFR value using pressure catheter relate to lesion prognosis or patient prognosis COmpaRed to aNatomical evaluation? |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2018/10/24 23:40:28 |
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Basic information
Public title
How does POst-PCI FFR value using pressure catheter relate to lesion prognosis or patient prognosis COmpaRed to aNatomical evaluation?
Acronym
POPCORN study
Scientific Title
How does POst-PCI FFR value using pressure catheter relate to lesion prognosis or patient prognosis COmpaRed to aNatomical evaluation?
Scientific Title:Acronym
POPCORN study
Region
| Japan |
Condition
Condition
stable angina, acute coronary syndrome
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to prospectively evaluate the relationship between fractional flow reserve immediately after percutaneous coronary intervention (PCI) and lesion prognosis or patient prognosis and to determine the cut-off value of post-PCI FFR
predicting 12-month clinical events.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fractional flow reserve immediately after percutaneous coronary intervention
Key secondary outcomes
Clinical events at 12 months (all cause death, cardiovascular death, non-fatal
myocardial infarction, clinically-driven target vessel revascularization, stent
thrombosis and stroke)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Fractional flow reserve immediately after percutaneous coronary intervention
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Age 20 years or over, 2.stable angina or acute coronary syndrome with significant residual stenosis in the non-culplit artery after primary PCI, 3.ability to provide
written informed consent
Key exclusion criteria
1. Left main coronary artery disease, 2.chronic total occlusion, 3. severe valvular
heart disease, 4. unstable hemodynamics, 5.contraindications to antiplatelet therapy or anticoagulant therapy, 6. severe liver disease, lung disease, and malignant disease
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Akasaka |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
Address
811-1, Kimiidera, Wakayama
TEL
073-447-2300
cvm4@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironori Kitabata |
Organization
Wakayama Medical University
Division name
Department of Cardiovascular Medicine
Zip code
Address
811-1, Kimiidera, Wakayama
TEL
073-447-2300
Homepage URL
cvm4@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 01 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035588
