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Important considerations for trials for peripheral arterial disease: Lessons learned from the paclitaxel mortality signal: A report on behalf of the registry assessment for peripheral interventional Devices (RAPID) Paclitaxel Pathways Program.
Lottes AE, Whatley EM, Royce SM, Bertges DJ, Erickson CA, Farb A, Fox ML, Jiang JH, Wang L, Lin AY, Malone ML, Papandreou G, Wilgus RW, Rosenfield K, Krucoff MW. Lottes AE, et al. Am Heart J. 2021 Feb;232:71-83. doi: 10.1016/j.ahj.2020.10.070. Epub 2020 Nov 4. Am Heart J. 2021. PMID: 33157067 Review.
Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.
Bertges DJ, White R, Cheng YC, Sun T, Ramkumar N, Goodney PP, Wilgus RW, Lottes AE, Smale JA, Drozda J, Raska M, Heise T, Jones WS, Tcheng JE, Eldrup-Jorgensen J, Sedrakyan A, Malone ML, Marinac-Dabic D, Thatcher R, Morales P, Krucoff MW, Cronenwett JL; Registry Assessment of Peripheral Interventional Devices (RAPID) and Superficial Femoral Artery-Popliteal EvidencE Development (SPEED) Study Group. Bertges DJ, et al. Among authors: lottes ae. J Vasc Surg. 2021 May;73(5):1702-1714.e11. doi: 10.1016/j.jvs.2020.09.030. Epub 2020 Oct 17. J Vasc Surg. 2021. PMID: 33080324 Free article.
Vascular Quality Initiative Surveillance of Femoropopliteal Artery Paclitaxel Devices.
Bertges DJ, Eldrup-Jorgensen J, Robbins S, Ssemaganda H, Malone M, Marinac-Dabic D, Smale J, Lottes AE, Majithia A, Resnic FS; Society for Vascular Surgery Vascular Quality Initiative. Bertges DJ, et al. Among authors: lottes ae. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2598-2609. doi: 10.1016/j.jcin.2021.08.058. JACC Cardiovasc Interv. 2021. PMID: 34887051 Free article.
Global Medical Device Clinical Trials Involving Both the United States and Japan: Key Considerations for Development, Regulatory Approval, and Conduct.
Iwamoto S, Cavanaugh K, Malone M, Lottes A, Thatcher R, Kumar K, Rowland S, Fearnot N, Uchida T, Iwaishi C, Senshu K, Konishi R, Ikeda K, Suzuki Y, Ikeno F, Tamura A, Ho M, Ohashi M, Katayama H, Krucoff MW. Iwamoto S, et al. Cardiovasc Revasc Med. 2023 Jul;52:67-74. doi: 10.1016/j.carrev.2023.02.015. Epub 2023 Feb 24. Cardiovasc Revasc Med. 2023. PMID: 36870799
Paclitaxel-Coated Zilver PTX Drug-Eluting Stent Treatment Does Not Result in Increased Long-Term All-Cause Mortality Compared to Uncoated Devices.
Dake MD, Ansel GM, Bosiers M, Holden A, Iida O, Jaff MR, Lottes AE, O'Leary EE, Saunders AT, Schermerhorn M, Yokoi H, Zeller T. Dake MD, et al. Among authors: lottes ae. Cardiovasc Intervent Radiol. 2020 Jan;43(1):8-19. doi: 10.1007/s00270-019-02324-4. Epub 2019 Sep 9. Cardiovasc Intervent Radiol. 2020. PMID: 31502026 Free PMC article. Clinical Trial.
Zilver PTX Post-market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan: 2-Year Results.
Kichikawa K, Ichihashi S, Yokoi H, Ohki T, Nakamura M, Komori K, Nanto S, O'Leary EE, Lottes AE, Snyder SA, Dake MD. Kichikawa K, et al. Among authors: lottes ae. Cardiovasc Intervent Radiol. 2019 Mar;42(3):358-364. doi: 10.1007/s00270-018-2110-1. Epub 2018 Nov 8. Cardiovasc Intervent Radiol. 2019. PMID: 30411151 Free PMC article.
23 results