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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030540
Receipt No. R000034867
Scientific Title The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter
Date of disclosure of the study information 2017/12/24
Last modified on 2017/12/24

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Basic information
Public title The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter
Acronym The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter
Scientific Title The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter
Scientific Title:Acronym The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter
Region
Japan

Condition
Condition Superficial femoral and proximal popliteal artery disease
Classification by specialty
Cardiology Surgery in general Vascular surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this surveillance (hereinafter, this surveillance) is to confirm the safety and efficacy
of the IN.PACT Admiral Drug-Coated Balloon Catheter (hereinafter, the product), and the compliance
status of proper use of the product based on the indication by the regulatory body in the real world conditions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Primary patency at 6 month post index procedure
Key secondary outcomes 1)Freedom from rate of clinical driven target lesions revascularization (CD-TLR) at 30 days, 6 months
and 12 months post index procedure
2)Procedure rate of all target lesions revascularization (TLR) at 30 days, 6 months and 12 months post
index procedure
3)Major adverse event (MAE) composite and its individual components (all-cause mortality, clinical
driven target vessel revascularization (CD-TVR), major target limb amputation, and thrombosis at
the target lesion site ) at each of the follow-up points including within 30 days, 6 months and 12
months.
4)Primary patency at 12 months post index procedure
5)Device Success defined as successful delivery, inflation, deflation and retrieval of the intact study
balloon device without burst below the rated burst pressure (RBP)
6)Procedural Success defined as residual stenosis of less than 50% (non-stented subjects) or less than 30% (stented subjects) by physician visual assessment
7)Clinical success defined as procedural success without procedural complications (death, major target
limb amputation, thrombosis of the target lesion, or TVR) prior to discharge
8)Adverse Events through discharge
9)Physician evaluation of successful on-label procedure

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 This product is indicated for percutaneous transluminal angioplastyof de novo and non-stented restenotic lesions with length less than 200 mm in superficial femoral and popliteal arteries with reference vessel diameters of more than 4 mm and less than 7 mm.
Key exclusion criteria NA
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Ono
Organization Medtronic Japan Co.,Ltd.
Division name Clinical Affairs, Post Market Clinical Research and Surveillance Division
Zip code
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL 03-6776-0007
Email hiroshi.ono@medtronic.com

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Ogura
Organization Medtronic Japan Co.,Ltd.
Division name Clinical Affairs, Post Market Clinical Research and Surveillance Division
Zip code
Address 1-2-70 Konan, Minato-ku, Tokyo
TEL 03-6776-0007
Homepage URL
Email tatsuya.ogura@medtronic.com

Sponsor
Institute Medtronic Japan Co.,Ltd.
Institute
Department

Funding Source
Organization NA
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2017 Year 12 Month 24 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 Preinitiation
Date of protocol fixation
2017 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 25 Day
Last follow-up date
2021 Year 03 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2021 Year 09 Month 05 Day

Other
Other related information NA

Management information
Registered date
2017 Year 12 Month 24 Day
Last modified on
2017 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034867

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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