Unique ID issued by UMIN | UMIN000048439 |
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Receipt number | R000054910 |
Scientific Title | Single-center observational study on the efficacy and safety of drug-coated balloons for vascular access intervention therapy |
Date of disclosure of the study information | 2022/08/01 |
Last modified on | 2022/07/23 09:47:03 |
observational study on the efficacy and safety of drug-coated balloons for dialysis arteriovenous fistula
observational study of drug-coated balloons for dialysis arteriovenous fistula
Single-center observational study on the efficacy and safety of drug-coated balloons for vascular access intervention therapy
Single-center observational study of drug-coated balloons for vascular access intervention therapy
Japan |
Dysfunctional dialysis arteriovenous fistula
Cardiology | Nephrology |
Others
NO
The rate of restenosis after balloon treatment is high for shunt stenosis during dialysis, and the effect of drug-coated balloons on preventing restenosis should be observed.
Safety,Efficacy
dialysis shunt patency rate after 6 months
Adverse event incidence
Observational
20 | years-old | <= |
Not applicable |
Male and Female
An example of satisfying the following situation of dialysis shunt
1) Restenosis cases
2) Stenosis rate 50% or more and lesion length 10 cm or less
3) Pre-balloon dilatation results in less than 30% residual stenosis and no serious dissection
4) No other prioritized treatment
Those who have offered to refuse participation
Those who are judged to be inappropriate as research subjects
120
1st name | Michiaki |
Middle name | |
Last name | Matsumoto |
Nihon University Hospital
Cardiology
101-8309
1-6 Surugadai kanda chiyoda-ku, Tokyo
0332931711
matsumoto.michiaki@nihon-u.ac.jp
1st name | Michiaki |
Middle name | |
Last name | Matsumoto |
Nihon University Hospital
Cardiology
101-8309
1-6 Surugadai kanda chiyoda-ku, Tokyo
0332931711
matsumoto.michiaki@nihon-u.ac.jp
Nihon University Hospital
Nihon University Hospital
Self funding
Nihon University Hospital
1-6 Surugadai kanda chiyoda-ku, Tokyo
0332931711
matsumoto.michiaki@nihon-u.ac.jp
NO
日本大学病院(東京都)
2022 | Year | 08 | Month | 01 | Day |
Unpublished
Preinitiation
2022 | Year | 05 | Month | 28 | Day |
2022 | Year | 08 | Month | 01 | Day |
2025 | Year | 07 | Month | 31 | Day |
Registry of routine clinical catheter treatment for dialysis shunt treatment. The primary endpoint is the shunt patency rate after 6 months.
2022 | Year | 07 | Month | 23 | Day |
2022 | Year | 07 | Month | 23 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054910
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