UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009551 |
|---|---|
| Receipt number | R000011206 |
| Scientific Title | A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent |
| Date of disclosure of the study information | 2012/12/15 |
| Last modified on | 2021/03/23 16:11:44 |
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Basic information
Public title
A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent
Acronym
RELIABLE
Scientific Title
A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent
Scientific Title:Acronym
RELIABLE
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 effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
The proportion of subjects who are free of target limb failure at 12-months post study procedure.
Key secondary outcomes
Primary patency, Secondary patency, Rutherford category assessment, ABI, Quality of life measurements, Major Adverse Events, all AEs and SAEs, TVR/TLR rates, and Freedom from Stent fracture rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
STENT
Interventions/Control_2
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
1. Rutherford Category 2-4 (mild intermittent claudication to ischemic pain at rest).
2. The target lesion(s) has evidence of narrowing or blockage and can be stented.
3. The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm.
Key exclusion criteria
1. The subject has concomitant renal failure with a creatinine of >2.5 mg/dl or having dialysis treatment.
2. Subject has a history of bypass surgery on the study vessel.
3. Subject has a history of MI or stroke within 6 months of study procedure.
Target sample size
70
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
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
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
| 2012 | Year | 12 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/avd/11/3/11_oa.18-00067/_article
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
Terminated
Date of protocol fixation
| 2012 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 14 | 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=R000011206
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
