UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020472 |
|---|---|
| Receipt number | R000021904 |
| Scientific Title | IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry |
| Date of disclosure of the study information | 2016/01/07 |
| Last modified on | 2016/02/02 12:49:39 |
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Basic information
Public title
IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry
Acronym
IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry: (IVORY)
Scientific Title
IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry
Scientific Title:Acronym
IntraVascular UltrasOund SuppoRted Endovascular Therapy in Superficial Femoral ArterY Disease Prospective multicenter registry: (IVORY)
Region
| Japan | Asia(except Japan) |
Condition
Condition
PAD: peripheral artery disease
Classification by specialty
| Cardiology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this research is to prospectively investigate the 12-month-safety and efficacy of intravascular ultrasound (IVUS) supported endovascular therapy (EVT) in patients with symptomatic peripheral artery disease (PAD) with a femoro-popliteal artery (FPA) lesion.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Twelve-month restenosis rate (Definition of restenosis;50% or more stenosis found on angiography or CTA, less than 2.4 PSVR found on duplex ultrasound)
Restenosis is basically evaluated by duplex 12 plus or minus months after endovascular procedure.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient has signed and dated the informed consent.
2) Patient has symptoms of atherosclerotic peripheral arterial disease classified as Rutherford Category1,,2, 3, 4 or 5.
3) Patient has a resting ABI less than 0.9 or an abnormal exercise ABI if resting ABI is normal. Patient with incompressible arteries (ABI greater than 1.2) must have a TBI less than 0.8.
4) Patient has a de novo or restenotic lesion with greater 50% stenosis documented angiographically in the target lesion.
5) Patient agrees to return for a clinical status assessment and duplex ultrasound post-procedure at 12 months.
Key exclusion criteria
1) Patient is under 18 years of age.
2) Patient is pregnant or breast-feeding.
3) Patient has significant stenosis (> 50%) or occlusion of inflow tract (proximal ipsilateral, iliofemoral, or aortic lesions) not successfully treated before this procedure (success is measured as smaller than 30% residual stenosis).
4) Patient has undergone an unsuccessful arterial interventional treatment of the legs (i.e., the treatment resulted in greater than 30% residual stenosis of a treated lesion) within 30 days prior to the study procedure.
5) Patient has any planned surgical or interventional procedure within 30 days after the study procedure.
6) Patient has a medical condition or disorder that would limit life expectancy to less than 1 year.
7) Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, or nitinol that, in the opinion of the investigator, cannot be adequately premedicated.
8) Patient has untreated angiographically-evident thrombus in the target lesion.
9) Patient has a bypass graft with an anastomosis in the target vessel.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Japan Labour Health and Welfare
Organization,
Kansai Rosai Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-69 Inabaso, Amagasaki-shi, 660-3511 Japan
TEL
06-6416-1221
iida.osa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Iida |
Organization
Japan Labour Health and Welfare Organization, Kansai Rosai Hospital
Division name
Department of Cardiovascular Medicine
Zip code
Address
3-1-69 Inabaso, Amagasaki-shi, 660-3511 Japan
TEL
06-6416-1221
Homepage URL
iida.osa@gmail.com
Sponsor or person
Institute
IVORY
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
| 2016 | Year | 01 | Month | 07 | 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
| 2015 | Year | 09 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | 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
| 2016 | Year | 01 | Month | 07 | Day |
Last modified on
| 2016 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021904
