Design Strategies for Global Clinical Trials of Endovascular Devices for Critical Limb Ischemia (CLI)ã- A Joint USA-Japanese Perspective.
Circ J
; 82(9): 2233-2239, 2018 08 24.
Article
em En
| MEDLINE
| ID: mdl-29962385
ABSTRACT
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.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Stents
/
Ensaios Clínicos como Assunto
/
Internacionalidade
/
Extremidades
/
Doença Arterial Periférica
/
Isquemia
Tipo de estudo:
Guideline
Limite:
Aged
/
Humans
País/Região como assunto:
America do norte
/
Asia
Idioma:
En
Revista:
Circ J
Assunto da revista:
ANGIOLOGIA
/
CARDIOLOGIA
Ano de publicação:
2018
Tipo de documento:
Article
País de publicação:
JAPAN
/
JAPON
/
JAPÃO
/
JP