UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049230 |
|---|---|
| Receipt number | R000056068 |
| Scientific Title | Prospective randomized trial of clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve guidance |
| Date of disclosure of the study information | 2022/10/16 |
| Last modified on | 2022/10/16 12:16:56 |
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Basic information
Public title
Prospective randomized trial of clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve guidance
Acronym
PROVISION study
Scientific Title
Prospective randomized trial of clinical outcomes of angiography-based fractional flow reserve guidance versus wire-based fractional flow reserve guidance
Scientific Title:Acronym
PROVISION study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the revascularization rate based on angiography-derived fractional flow reserve compared to that based on angiography-derived fractional flow reserve.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Revascularization rate based on angiography-derived fractional flow reserve compared to that based on fractional flow reserve
Key secondary outcomes
Adverse events after one year(cardiac death, myocardial infarction, ischemia-driven revascularization, stroke, hospitalization due to heart failure)
Costs of cardiac catheterization and revascularization
Costs of adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment based on FFRangio asesssment
Interventions/Control_2
Treatment based on FFR asessment
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
| 120 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Patients for whom PCI is appropriate
2)Lesions whose visual diameter stenosis is greater than or equal to 30% and less than 90%
3)Lesions whose visual reference vessel diameter is greater than or equal to 2mm
Key exclusion criteria
1)Patients for whom PCI is not appropriate
2)Patients with within 72 hours of acute coronary syndrome
3)Patients with severe bronchial asthma or chronic obstructive pulmonary disease
4)Patients with heart failure categorized as NYHA class III or IV
5)Patients with allergy to contrast media
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Matsuo |
Organization
Gifu Heart Center
Division name
Cardiology
Zip code
500-8384
Address
4-14-4 Yabutaminami, Gifu city, Gifu
TEL
058-277-2277
matsuo@heart-center.or.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Tanigaki |
Organization
Gifu Heart Center
Division name
Cardiology
Zip code
500-8384
Address
4-14-4 Yabutaminami, Gifu city, Gifu
TEL
058-277-2277
Homepage URL
tanigaki@heart-center.or.jp
Sponsor or person
Institute
Gifu Heart Center
Institute
Department
Personal name
Funding Source
Organization
Gifu Heart Center
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
Gifu Heart Center Institutional Review Board
Address
4-14-4 Yabutaminami, Gifu city, Gifu
Tel
058-277-2277
tomita@heart-center.or.jp
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
| 2022 | Year | 10 | Month | 16 | 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
400
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 11 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 10 | Month | 16 | Day |
Last modified on
| 2022 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056068
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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