Unique ID issued by UMIN | UMIN000014673 |
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Receipt number | 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 | 2021/03/23 15:22:12 |
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
Lutonix BTK - HD Trial
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
Lutonix BTK - HD Trial
Japan |
Symptomatic occlusive disease of the peripheral arteries
Cardiology | Vascular surgery | Radiology |
Others
NO
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.
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
- Freedom from BTK MALE+POD at 30-Days
- Composite of limb salvage and primary patency at 6 months
Primary patency, Hemodynamic outcome, Clinically-driven TLR, and wound healing
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
2
Treatment
Device,equipment |
PTA
PTA
20 | years-old | <= |
80 | years-old | > |
Male and Female
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.
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.
72
1st name | Masato |
Middle name | |
Last name | Nakamura |
Ohashi Hospital of Toho University Medical Center
Cardiovascular internal medicine
153-0044
2-22-36, Ohashi, Meguro-ku, Tokyo
03-3468-1251
medicon-clinicaltrial@crbard.com
1st name | Soji |
Middle name | |
Last name | Iida |
Medicon Inc.
Clinical Development
541-0046
2-5-8, Hiranomachi, Chuo-ku, Osaka
06-6203-6567
Soji.Iida@bd.com
Medicon Inc.
Medicon Inc.
Profit organization
Japan
N/A
N/A
N/A
N/A
NO
2014 | Year | 07 | Month | 29 | Day |
Unpublished
36
Completed
2014 | Year | 02 | Month | 13 | Day |
2014 | Year | 05 | Month | 23 | Day |
2014 | Year | 07 | Month | 30 | Day |
2019 | Year | 02 | Month | 05 | Day |
2014 | Year | 07 | Month | 28 | Day |
2021 | Year | 03 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016953
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