Unique ID issued by UMIN | UMIN000036798 |
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Receipt number | R000041929 |
Scientific Title | Real DES study -Zilver PTX vs Eluvia for femoropopliteal disease in multicenter prospective study- |
Date of disclosure of the study information | 2019/05/20 |
Last modified on | 2022/05/24 19:54:02 |
Real DES study
-Zilver PTX vs Eluvia for femoropopliteal disease in multicenter prospective study-
Real DES study
Real DES study
-Zilver PTX vs Eluvia for femoropopliteal disease in multicenter prospective study-
Real DES study
Japan |
Obstructive arteriosclerosis of superficial femoral artery lesion.
Vascular surgery |
Others
NO
We compare the effectiveness and safety of
Eluvia and Zilver PTX in long-term clinical practice in Japan and explore related factors.
Safety,Efficacy
Not applicable
Of the first year primary patency/secondary patency
Observational
20 | years-old | <= |
Not applicable |
Male and Female
1) 20 years old or older.
2) Atherosclerosis, with symptoms of peripheral artery disease (Rutherford Category 1 to 6).
3) Resting ABI is less than 0.9. Or, if the ABI is 0.9 or more, ischemia is evaluated in another test.
4) A stenosis evaluated by angiography or CT or MRI in the FPA area shows 50% or more or occlusion, or a stenosis or occlusion of PSVR> 2.4 in vascular echo (whether a new lesion or a restenotic lesion does not matter)
1) Significant constriction (50% or more) in the ipsilateral proximal CFA or iliac artery area or aorta, or unsuccessful (30% or more residual stenosis) inflowing stenosis or occlusion before this procedure . However, if simultaneous treatment (EVT for iliac and femoral arteries) is planned, entry is possible.
2) Surgical bypass surgery and major amputation are planned within 30 days after EVT.
3) Cases with untreated angiographically evident thrombi in the target lesion
4) Cases with anastomotic lesions after bypass surgery
400
1st name | Tsuyoshi |
Middle name | |
Last name | Shibata |
Hakodate Municipal Hospital
Cardiovascular surgery
041-0821
Minatocho 1-10-1 Hakodate Hokkaido Japan
0138-43-2000
shibatatsuyoshi0827@yahoo.co.jp
1st name | Tsuyoshi |
Middle name | |
Last name | Shibata |
Hakodate Municipal Hospital
Cardiovascular surgery
041-0821
Minatocho 1-10-1 Hakodate Hokkaido Japan
0138-43-2000
shibatatsuyoshi0827@yahoo.co.jp
Hakodate Municipal Hospital
Hakodate Municipal Hospital
Local Government
Hakodate Municipal Hospital
Minatocho 1-10-1 Hakodate Hokkaido Japan
0138-43-2000
shibatatsuyoshi0827@yahoo.co.jp
NO
総合南東北病院、水戸協同病院、釧路孝仁会病院、九州医療センター、土谷総合病院、函館五稜郭病院、春日井市民病院、京都第二赤十字病院、済生会和歌山病院、山口県立総合医療センター
2019 | Year | 05 | Month | 20 | Day |
Unpublished
Open public recruiting
2019 | Year | 02 | Month | 07 | Day |
2019 | Year | 02 | Month | 07 | Day |
2019 | Year | 02 | Month | 07 | Day |
2023 | Year | 09 | Month | 30 | Day |
Participants'study period
Participants will participate in the 36-month observation period after agreeing
Observation and inspection items
Collect the following data.
-Patient background (gender, age, walking condition, hypertension, lipid abnormalities, diabetes, kidney disease, smoking condition, coronary artery disease, cerebrovascular disorder, heart failure, atrial fibrillation, medication status)
-Affected limb background (classification of clinical severity (Rutherford classification), ABI (ankle-brachial index), degree of calcification (PACSS Grade), run-off number of peripheral arteries)
-Lesion background, angiography evaluation (TASC II Classification, lesion, vascular diameter, lesion type, stenosis, lesion length, occlusion length, calcification, lesion morphology, pre-placement stent (ISR, Tosaka classification), EVT pre-IVUS findings) -Treatment information (actual treatment content (puncture method, use guide wire, use device, treatment time, contrast agent amount, post-treatment vascular morphology, stent type, stent size, pre balloon diameter, pre extension time, pre extended pressure/post
Balloon diameter, Post extension time, post extended pressure))
-Lesion (subknee artery or upper knees and aortic iliac artery merger)
-PSVR of the target vessels by the lower extremity artery echo (Treatment 1.3, 6, 12 months later)
-Post-treatment information (ABI and perioperative complications after treatment)
-Tracking Survey (reason), death (cause of death), large leg cutting, surgical revascularization migration, re-treatment, ischemic ulcer healing and medication status)
-Image inspection information such as vascular imaging inspection and CT examination
2019 | Year | 05 | Month | 20 | Day |
2022 | Year | 05 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041929
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