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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020472
Receipt No. 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

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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
Email 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
Email iida.osa@gmail.com

Sponsor
Institute IVORY
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021904

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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