UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010358 |
|---|---|
| Receipt number | R000012115 |
| Scientific Title | A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2021/03/23 16:21:29 |
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Basic information
Public title
A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
Acronym
LEVANT Japan
Scientific Title
A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB vs. Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries
Scientific Title:Acronym
LEVANT Japan
Region
| Japan |
Condition
Condition
Symptomatic occlusive disease of the peripheral arteries
Classification by specialty
| Cardiology | Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Primary Patency at 6 months.
Key secondary outcomes
Primary and Secondary Patency
Target Lesion Revascularization (TLR)
Rutherford classification
Resting Ankle Brachial Index rate (ABI)
Walking Impairment Questionnaire
Quality of life score
Death
Amputation (above the ankle)-Free Survival (AFS)
Target Vessel Revascularization (TVR)
Major vascular complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
PTA
Interventions/Control_2
PTA
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Male or non-pregnant female >=20 years of age
-Rutherford Clinical Category 2-4
-Length <=15 cm
->=70% stenosis
-Lesion location starts >=1 cm below the common femoral bifurcation and terminates distally <=2 cm below the tibial plateau AND >=1 cm above the origin of the TP trunk
-A patent inflow artery as confirmed by angiography
-At least one patent native outflow artery to the ankle
Key exclusion criteria
-Life expectancy of < 2 years
-History of hemorrhagic stroke within 3 months
-Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure
-History of MI, thrombolysis or angina within 2 weeks of enrollment
-Renal failure or chronic kidney disease
-Severe calcification that renders the lesion un-dilatable
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | - |
| Middle name | |
| Last name | 1)Hiroyoshi Yokoi, 2)Osamu Iida |
Organization
1)Fukuoka Sanno Hospital, 2)Kansai Rosai Hospital
Division name
1)Cardiovascular Medicine Center, 2)Cardiovascular internal medicine
Zip code
1)814-0001, 2)660-0064
Address
1)3-6-45, Momochihama, Sawara-ku, Fukuoka-shi, Fukuoka, 2)3-1-69, Inabaso, Amagasaki-shi, Hyogo
TEL
-
medicon-clinicaltrial@crbard.com
Public contact
Name of contact person
| 1st name | Soji |
| Middle name | |
| Last name | Iida |
Organization
Medicon Inc.
Division name
Clinical Development
Zip code
541-0046
Address
2-5-8, Hiranomachi, Chuo-ku, Osaka-shi, Osaka
TEL
06-6203-6567
Homepage URL
Soji.Iida@bd.com
Sponsor or person
Institute
Medicon Inc.
Institute
Department
Personal name
Funding Source
Organization
Medicon Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
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
| 2013 | 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
Completed
Date of protocol fixation
| 2012 | Year | 11 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 13 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 03 | Month | 29 | Day |
Last modified on
| 2021 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012115
| 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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| Registered date | File name |
