UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018614 |
|---|---|
| Receipt number | R000021542 |
| Scientific Title | Clinical impact of post-procedural fractional flow reserve on future restenosis in superficial femoral artery disease |
| Date of disclosure of the study information | 2015/08/09 |
| Last modified on | 2015/08/10 16:27:30 |
* 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
Clinical impact of post-procedural fractional flow reserve on future restenosis in superficial femoral artery disease
Acronym
post-procedural fractional flow reserve for superficial femoral aretery disease and restenosis
Scientific Title
Clinical impact of post-procedural fractional flow reserve on future restenosis in superficial femoral artery disease
Scientific Title:Acronym
post-procedural fractional flow reserve for superficial femoral aretery disease and restenosis
Region
| Japan |
Condition
Condition
superficial femoral artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the clinical impact of post endovascular therapy fractional flow reserve for superficial femoral artery disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
restenosis rate
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
successful endovascular therapy for superficial femoral artery disease
Key exclusion criteria
patients with aneurysm or stenosis at aorta or iliac artery, patients with congestive heart failure (New York Heart Association functional class 3-4), patients with severe pulmonary hypertension as evidenced by ultrasound cardiography, patients with no run-off vessel.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Kobayashi |
Organization
Saiseikai Yokohama-city Eastern Hospital
Division name
Cardiology
Zip code
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, JAPAN
TEL
+81-45-576-3000
ovation17@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiro Kobayashi |
Organization
Saiseikai Yokohama City Eastern Hospital
Division name
Cardiology
Zip code
Address
3-6-1 Shimosueyoshi, Tsurumi-ku, Yokohama, Kanagawa, JAPAN
TEL
+81-45-576-3000
Homepage URL
ovation17@gmail.com
Sponsor or person
Institute
Saiseikai Yokohama City Eastern Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2015 | Year | 08 | Month | 09 | 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
Completed
Date of protocol fixation
| 2013 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | 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
To evaluate the clinical impact of post endovascular therapy fractional flow reserve for superficial femoral artery disease.
Singlecenter, prospective, observational study. We perform FFR measurement after endovascula therapy for superficial femoral artery disease.
Management information
Registered date
| 2015 | Year | 08 | Month | 09 | Day |
Last modified on
| 2015 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021542
