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Recruitment status Completed
Unique ID issued by UMIN UMIN000014673
Receipt No. R000016953
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
Date of disclosure of the study information 2014/07/29
Last modified on 2019/08/13

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Nakamura
Organization Ohashi Hospital of Toho University Medical Center
Division name Cardiovascular internal medicine
Zip code
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
Middle name
Last name Kadono
Organization Medicon Inc.
Division name Regulatory and Clinical Affairs
Zip code
Address 2-5-8, Hiranomachi, Chuo-ku, Osaka
TEL 06-6203-6560
Homepage URL
Email Yoshihiko.Kadono@crbard.com

Sponsor
Institute Medicon Inc.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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
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
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
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
2019 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016953


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