UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030540
Receipt number 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 2022/01/05 15:58:26

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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 Akira
Middle name
Last name Kikuchi

Organization

Medtronic Japan Co.,Ltd.

Division name

Post Market Surveillance, Japan Clinical and Medical Affairs

Zip code

108-0075

Address

1-2-70 Konan, Minato-ku, Tokyo

TEL

03-6776-0007

Email

akira.kikuchi@medtronic.com


Public contact

Name of contact person

1st name Kei
Middle name
Last name Harada

Organization

Medtronic Japan Co.,Ltd.

Division name

Post Market Surveillance, Japan Clinical and Medical Affairs

Zip code

108-0075

Address

1-2-70 Konan, Minato-ku, Tokyo

TEL

03-6776-0007

Homepage URL


Email

kei.harada@medtronic.com


Sponsor or person

Institute

Medtronic Japan Co.,Ltd.

Institute

Department

Personal name



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

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

2017 Year 12 Month 24 Day


Related information

URL releasing protocol

N/A

Publication of results

Partially published


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-21-0491/_article/-char/ja/

Number of participants that the trial has enrolled

307

Results

Please refer to partially published data or documents/results released by PMDA (regulatory body).

Results date posted

2022 Year 01 Month 05 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 10 Month 08 Day

Baseline Characteristics

N/A

Participant flow

Enrollment Center System

Adverse events

N/A

Outcome measures

Please refer to partially published data or documents/results released by PMDA (regulatory body).

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 12 Month 15 Day

Date of IRB

2017 Year 12 Month 25 Day

Anticipated trial start date

2018 Year 01 Month 26 Day

Last follow-up date

2020 Year 09 Month 08 Day

Date of closure to data entry

2021 Year 06 Month 30 Day

Date trial data considered complete

2021 Year 09 Month 05 Day

Date analysis concluded

2021 Year 11 Month 05 Day


Other

Other related information

NA


Management information

Registered date

2017 Year 12 Month 24 Day

Last modified on

2022 Year 01 Month 05 Day



Link to view the page

Value
https://center6.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