Unique ID issued by UMIN | UMIN000030540 |
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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 |
The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter
The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter
The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter
The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter
Japan |
Superficial femoral and proximal popliteal artery disease
Cardiology | Surgery in general | Vascular surgery |
Others
NO
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.
Safety,Efficacy
Others
Others
Not applicable
Primary patency at 6 month post index procedure
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
Observational
Not applicable |
Not applicable |
Male and Female
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.
NA
300
1st name | Akira |
Middle name | |
Last name | Kikuchi |
Medtronic Japan Co.,Ltd.
Post Market Surveillance, Japan Clinical and Medical Affairs
108-0075
1-2-70 Konan, Minato-ku, Tokyo
03-6776-0007
akira.kikuchi@medtronic.com
1st name | Kei |
Middle name | |
Last name | Harada |
Medtronic Japan Co.,Ltd.
Post Market Surveillance, Japan Clinical and Medical Affairs
108-0075
1-2-70 Konan, Minato-ku, Tokyo
03-6776-0007
kei.harada@medtronic.com
Medtronic Japan Co.,Ltd.
NA
Self funding
N/A
N/A
N/A
N/A
NO
2017 | Year | 12 | Month | 24 | Day |
N/A
Partially published
https://www.jstage.jst.go.jp/article/circj/advpub/0/advpub_CJ-21-0491/_article/-char/ja/
307
Please refer to partially published data or documents/results released by PMDA (regulatory body).
2022 | Year | 01 | Month | 05 | Day |
2021 | Year | 10 | Month | 08 | Day |
N/A
Enrollment Center System
N/A
Please refer to partially published data or documents/results released by PMDA (regulatory body).
Completed
2017 | Year | 12 | Month | 15 | Day |
2017 | Year | 12 | Month | 25 | Day |
2018 | Year | 01 | Month | 26 | Day |
2020 | Year | 09 | Month | 08 | Day |
2021 | Year | 06 | Month | 30 | Day |
2021 | Year | 09 | Month | 05 | Day |
2021 | Year | 11 | Month | 05 | Day |
NA
2017 | Year | 12 | Month | 24 | Day |
2022 | Year | 01 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034867
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