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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033747
Receipt No. 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 2021/03/23

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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
Email 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
Email Soji.Iida@bd.com

Sponsor
Institute Medicon Inc.
Institute
Department

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
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
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 No longer recruiting
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 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=R000038495

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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