Unique ID issued by UMIN | UMIN000033747 |
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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 |
The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)
The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)
The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)
The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)
Japan |
Femoropopliteal artery disease
Cardiology | Vascular surgery | Radiology |
Others
NO
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.
Efficacy
Primary patency at 6 and 12 months post procedure
- 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
Observational
Not applicable |
Not applicable |
Male and Female
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.
NA
370
1st name | Soji |
Middle name | |
Last name | Iida |
Medicon Inc.
Clinical Development
541-0046
2-5-8, Hiranomachi, Chuo-ku, Osaka
06-6203-6567
Soji.Iida@bd.com
1st name | Soji |
Middle name | |
Last name | Iida |
Medicon Inc.
Clinical Development
541-0046
2-5-8, Hiranomachi, Chuo-ku, Osaka
06-6203-6567
Soji.Iida@bd.com
Medicon Inc.
Medicon Inc.
Self funding
Japan
N/A
N/A
N/A
N/A
NO
2018 | Year | 08 | Month | 14 | Day |
Partially published
Completed
2017 | Year | 09 | Month | 26 | Day |
2017 | Year | 10 | Month | 27 | Day |
2017 | Year | 11 | Month | 17 | Day |
2021 | Year | 09 | Month | 30 | Day |
NA
2018 | Year | 08 | Month | 14 | Day |
2021 | Year | 12 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038495
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