UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033747 |
|---|---|
| Receipt number | R000038495 |
| Scientific Title | The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery) |
| Date of disclosure of the study information | 2018/08/14 |
| Last modified on | 2021/12/08 10:07:30 |
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Basic information
Public title
The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)
Acronym
The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)
Scientific Title
The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)
Scientific Title:Acronym
The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)
Region
| Japan |
Condition
Condition
Femoropopliteal artery disease
Classification by specialty
| Cardiology | Vascular surgery | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm whether the efficacy equivalent to those of Lutonix Drug Coated Balloon Group demonstrated in LEVANT Japan study and to investigate safety in actual clinical setting.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary patency at 6 and 12 months post procedure
Key secondary outcomes
- Target Limb Reintervention, unscheduled target limb amputation and target limb related death during the follow-up period
- SAE during the follow-up period, which the relation to device or procedure cannot be denied
- Device malfunction and adverse event during the follow-up period which the relation to device or procedure cannot be denied
- Freedom from clinically-driven (including ABI, Rutherford Classification) TLR at 1 month, 6 months and 12 months post procedure
- Duration of Lutonix DCB related DAPT at pre-procedure and during follow-up period
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients within the scope indicated for the device, and presenting with de novo lesion(s) or restenotic lesion(s) (excluding in-stent stenosis) in the superficial femoral or popliteal artery with the reference vessel diameter of >=4 mm and <= 6 mm and length of <=15 cm who are treated in the sites contracted for the surveillance.
Key exclusion criteria
NA
Target sample size
370
Research contact person
Name of lead principal investigator
| 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
Soji.Iida@bd.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
Self funding
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
| 2018 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 09 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2018 | Year | 08 | Month | 14 | Day |
Last modified on
| 2021 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038495
