UMIN-CTR Clinical Trial

Basic information
Public title	A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries in Patients Undergoing Hemodialysis
Acronym	Lutonix BTK - HD Trial
Scientific Title	A Prospective, Multicenter, Single Blind, Randomized, Controlled Trial Comparing the Lutonix Drug Coated Balloon vs. Standard Balloon Angioplasty for Treatment of Below-the-Knee (BTK) Arteries in Patients Undergoing Hemodialysis
Scientific Title:Acronym	Lutonix BTK - HD Trial
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	The purpose of this study is to assess the safety and efficacy of the Lutonix DCB for treatment of stenosis or occlusion of native below-the-knee arteries in the Japanese HD population.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	- Freedom from BTK MALE+POD at 30-Days - Composite of limb salvage and primary patency at 6 months
Key secondary outcomes	Primary patency, Hemodynamic outcome, Clinically-driven TLR, and wound healing

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1. Male or non-pregnant, non-breastfeeding female >=20 but <80 years of age; 2. Rutherford Clinical Category 4-5; 3. Life expectancy >=1 year; 4. Patient has been receiving chronic hemodialysis treatments (>=3 times per week) for End Stage Renal Disease (ESRD) for >=3 months (NOTE: Peritoneal dialysis treatments are not allowed); 5. Significant stenosis (>=70%) or occlusion of native artery(s) above the tibiotalar joint; etc.
Key exclusion criteria	1. History of stroke within 3 months; 2. History of MI, thrombolysis or angina within 30 days of enrollment; 3. Prior or planned major amputation (of either leg); etc.
Target sample size	72

Research contact person
Name of lead principal investigator	1st name Masato Middle name Last name Nakamura
Organization	Ohashi Hospital of Toho University Medical Center
Division name	Cardiovascular internal medicine
Zip code	153-0044
Address	2-22-36, Ohashi, Meguro-ku, Tokyo
TEL	03-3468-1251
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
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	2014 Year 07 Month 29 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	36
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	2014 Year 02 Month 13 Day
Date of IRB	2014 Year 05 Month 23 Day
Anticipated trial start date	2014 Year 07 Month 30 Day
Last follow-up date	2019 Year 02 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2014 Year 07 Month 28 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=R000016953