Unique ID issued by UMIN | UMIN000041208 |
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Receipt number | R000047055 |
Scientific Title | Patient-level meta-analysis of mortality from paclitaxel-containing device in Japanese patients with symptomatic superficial femoral artery disease. |
Date of disclosure of the study information | 2020/08/04 |
Last modified on | 2020/07/25 18:05:58 |
Long-term safety of paclitaxel containing devices in Japan
The use of paclitaxel containing devices and mortality
Patient-level meta-analysis of mortality from paclitaxel-containing device in Japanese patients with symptomatic superficial femoral artery disease.
META-JAPAN
Japan |
Peripheral artery disease
Cardiology |
Others
NO
Assessment of safety of paclitaxel containing devices on the long-term prognosis
Safety
cumulative 5year all cause death
Others,meta-analysis etc
20 | years-old | <= |
100 | years-old | > |
Male and Female
Eligible trials were limited to approved devices as of March 2019 for use in the femoropopliteal artery, had a follow- up period of >1 year, and were conducted in Japan under good clinical practice (GCP) or good post-marketing study practice (GPSP).
Clinical trials
1. not approved device in Japan
2. not conducted under GCP or GPSP guidance
2500
1st name | Masato |
Middle name | |
Last name | Nakamura |
Toho University, Ohashi Medical Center
Division of cardiovascular Medicine
153-8515
2-22-36 Ohashi Meguroku Tokyo 153-8515 Japan
03-3468-1251
masato@oha.toho-u.ac.jp
1st name | Masato |
Middle name | |
Last name | Nakamura |
Toho University, Oahshi Medical Center
Division of Cardiovascular Medicine
153-8515
2-22-36 Ohashi Meguroku Tokyo 153-8515 Japan
0334681251
masato@oha.toho-u.ac.jp
Toho University
Grant from MHLW
Japanese Governmental office
Toho University, Faculty of Medicine
5-21-16 Omori Nishi Otaku Tokyo 143-8540 Japan
0337624151
masato@oha.toho-u.ac.jp
NO
2020 | Year | 08 | Month | 04 | Day |
Unpublished
2599
No longer recruiting
2019 | Year | 11 | Month | 01 | Day |
2019 | Year | 12 | Month | 03 | Day |
2019 | Year | 12 | Month | 14 | Day |
2020 | Year | 12 | Month | 31 | Day |
Six companies had Japanese clinical trial data on endovascular treatment for symptomatic superficial femoral artery disease. With the corporation of the companies, individual data from all trials will be integrated and a patient-level meta-analysis will be conducted.
Estimated PTXD are 1153 cases, including 2 types of DCB (n = 388) and 2 types of DES (n = 1,014), non-PTXD are 894 cases, bare metal stent (n = 996) and balloon angioplasty (n = 201). A primary endpoint is all cause death and cumulative mortality will be estimated by the Kaplan-Meier curve. Five-year mortality with PTXD and non-PTXD will be compared to the log-rank test. Secondary endpoints are cumulative incidence of amputation and cause of death. Death will be classified as cardiovascular and non-cardiovascular. Non-cardiovascular death will be further classified into malignancy, infectious diseases and others.
2020 | Year | 07 | Month | 25 | Day |
2020 | Year | 07 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047055
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