Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI) ― A Joint USA-Japanese Perspective ―
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- Yokoi Hiroyoshi
- Department of Cardiovascular Medicine, Fukuoka Sanno Hospital
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- Ho Mami
- Office of Medical Devices III, Pharmaceuticals and Medical Devices Agency
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- Iwamoto Shin
- Office of Medical Devices II, Pharmaceuticals and Medical Devices Agency
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- Suzuki Yuka
- Tohoku University Hospital
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- Ansel Gary M.
- Center for Critical Limb Care, OhioHealth/Riverside Methodist Hospital
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- Azuma Nobuyoshi
- Department of Vascular Surgery, Asahikawa Medical University
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- Handa Nobuhiro
- Office of Medical Devices III, Pharmaceuticals and Medical Devices Agency
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- Iida Osamu
- Cardiovascular Center, Kansai Rosai Hospital
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- Ikeda Koji
- Tohoku University Hospital
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- Ikeno Fumiaki
- Stanford University
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- Ohura Norihiko
- Department of Plastic and Reconstructive Surgery, Kyorin University School of Medicine
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- Rosenfield Kenneth
- Department of Cardiology, Massachusetts General Hospital
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- Rundback John
- Holy Name Medical Center
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- Terashi Hiroto
- Department of Plastic Surgery, Kobe University Graduate School of Medicine
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- Uchida Takahiro
- Department of Cardiology, Tokyo Women’s Medical University
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- Yokoi Yoshiaki
- Department of Cardiology, Kishiwada Tokushukai Hospital
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- Nakamura Masato
- Division of Cardiovascular Medicine, Toho University, Ohashi Medical Center
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- Jaff Michael R.
- VasCore, Massachusetts General Hospital
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<p>For more than 10 years, the Harmonization by Doing (HBD) program, a joint effort by members from academia, industry and regulators from the United States of America (USA) and Japan, has been working to increase timely regulatory approval for cardiovascular devices through the development of practical global clinical trial paradigms. Consistent with this mission and in recognition of the increasing global public health effects of critical limb ischemia (CLI), academic and government experts from the USA and Japan have developed a basic framework of global clinical trials for endovascular devices for CLI. Despite differences in medical and regulatory environments and complex patient populations in both countries, we developed a pathway for the effective design and conduct of global CLI device studies by utilizing common study design elements such as patients’ characteristics and study endpoints, and minimizing the effect of important clinical differences. Some of the key recommendations for conducting global CLI device studies are: including patients on dialysis; using a composite primary endpoint for effectiveness that includes 6-month post-procedure therapeutic success and target vessel patency; and using a 30-day primary safety endpoint of perioperative death and major adverse limb events. The proposed approach will be uniquely beneficial in facilitating both the initiation and interpretation of CLI studies and accelerating worldwide CLI device development and innovation.</p>
収録刊行物
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- Circulation Journal
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Circulation Journal 82 (9), 2233-2239, 2018-08-24
一般社団法人 日本循環器学会
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詳細情報 詳細情報について
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- CRID
- 1390564238015614592
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- NII論文ID
- 130007439007
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- NII書誌ID
- AA11591968
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- ISSN
- 13474820
- 13469843
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- NDL書誌ID
- 029172110
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- PubMed
- 29962385
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- 本文言語コード
- en
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- データソース種別
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- JaLC
- NDL
- Crossref
- PubMed
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