UMIN-CTR Clinical Trial

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	-
Email	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
Email	Soji.Iida@bd.com

Sponsor
Institute	Medicon Inc.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012115