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Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept.

Publication ,  Journal Article
Martinsen, BJ; Kumar, K; Saito, S; Sharma, SK; Ikeno, F; Fearnot, NE; Shlofmitz, RA; Thatcher, R; Krucoff, MW
Published in: Cardiovasc Revasc Med
April 2022

Effective treatment strategies and medical devices continue to be needed in Japan and the United States of America (US) to mitigate the growing burden of cardiovascular disease and coronary heart disease. Unfortunately, there can be a delay in gaining cardiovascular device approval in Japan after a device has already been approved and is in use in the US. The Harmonization by Doing (HBD) program; however, can eliminate this delay and reduce the cost of completing a clinical trial in Japan. The HBD proof-of-concept study, COAST, resulted in approval of the Diamondback 360® Coronary Orbital Atherectomy System Micro Crown simultaneously in Japan and the US on the same day. Subsequently, the Diamondback 360® Coronary OAS Classic Crown also received approval in Japan. The COAST study provides further evidence that global clinical trials via HBD for medical devices are practical and advantageous.

Duke Scholars

Published In

Cardiovasc Revasc Med

DOI

EISSN

1878-0938

Publication Date

April 2022

Volume

37

Start / End Page

112 / 117

Location

United States

Related Subject Headings

  • Vascular Calcification
  • United States
  • Treatment Outcome
  • Severity of Illness Index
  • Percutaneous Coronary Intervention
  • Japan
  • Humans
  • Coronary Artery Disease
  • Coronary Angiography
  • Cardiovascular System & Hematology
 

Citation

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Martinsen, B. J., Kumar, K., Saito, S., Sharma, S. K., Ikeno, F., Fearnot, N. E., … Krucoff, M. W. (2022). Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept. Cardiovasc Revasc Med, 37, 112–117. https://doi.org/10.1016/j.carrev.2021.08.021
Martinsen, Brad J., Katherine Kumar, Shigeru Saito, Samin K. Sharma, Fumiaki Ikeno, Neal E. Fearnot, Richard A. Shlofmitz, Robert Thatcher, and Mitchell W. Krucoff. “Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept.Cardiovasc Revasc Med 37 (April 2022): 112–17. https://doi.org/10.1016/j.carrev.2021.08.021.
Martinsen BJ, Kumar K, Saito S, Sharma SK, Ikeno F, Fearnot NE, et al. Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept. Cardiovasc Revasc Med. 2022 Apr;37:112–7.
Martinsen, Brad J., et al. “Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept.Cardiovasc Revasc Med, vol. 37, Apr. 2022, pp. 112–17. Pubmed, doi:10.1016/j.carrev.2021.08.021.
Martinsen BJ, Kumar K, Saito S, Sharma SK, Ikeno F, Fearnot NE, Shlofmitz RA, Thatcher R, Krucoff MW. Japan-USA Orbital Atherectomy for Calcific Coronary Lesions: COAST Study, Harmonization by Doing Proof-of-Concept. Cardiovasc Revasc Med. 2022 Apr;37:112–117.
Journal cover image

Published In

Cardiovasc Revasc Med

DOI

EISSN

1878-0938

Publication Date

April 2022

Volume

37

Start / End Page

112 / 117

Location

United States

Related Subject Headings

  • Vascular Calcification
  • United States
  • Treatment Outcome
  • Severity of Illness Index
  • Percutaneous Coronary Intervention
  • Japan
  • Humans
  • Coronary Artery Disease
  • Coronary Angiography
  • Cardiovascular System & Hematology