{"id":75473,"date":"2020-04-28T08:24:20","date_gmt":"2020-04-28T13:24:20","guid":{"rendered":"https:\/\/pulmonx.com\/stelvio-etude-clinique\/"},"modified":"2021-05-03T14:46:31","modified_gmt":"2021-05-03T19:46:31","slug":"stelvio-etude-clinique","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/fr\/stelvio-etude-clinique\/","title":{"rendered":"STELVIO \u00c9tude clinique"},"content":{"rendered":"\n
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\n \"PMX-Corporate-Website-Assets_ForTranslation-French-STELVIO-Logo\" \n <\/div>\n \n \n <\/div>\n\n
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\u00ab Le traitement par la valve endobronchique chez les patients pr\u00e9sentant un emphys\u00e8me et l\u2019absence av\u00e9r\u00e9e de ventilation collat\u00e9rale interlobaire ont apport\u00e9 un b\u00e9n\u00e9fice clinique mesurable, avec une am\u00e9lioration significative de la fonction respiratoire, de la capacit\u00e9 \u00e0 faire de l\u2019exercice et de la qualit\u00e9 de vie par rapport \u00e0 un traitement m\u00e9dical st standard. \u00bb4<\/sup><\/a><\/p>\n<\/blockquote> <\/div>\n<\/div>\n\n

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\n \n T\u00e9l\u00e9charger le r\u00e9sum\u00e9 de l'\u00e9tude <\/a>\n <\/div>\n <\/div>\n\n <\/div>\n
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Publi\u00e9 dans la revue New England Journal of Medicine4<\/sup><\/a><\/h1>\n

Le premier essai clinique prospectif, contr\u00f4l\u00e9 et randomis\u00e9 qui utilise Chartis\u00ae <\/sup>pour s\u00e9lectionner les bons candidats au traitement par la valve endobronchique Zephyr.<\/p>\n

M\u00e9thodes et crit\u00e8res d\u2019\u00e9valuation<\/b><\/h3>\n
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  • 68 patients pr\u00e9sentant une ventilation collat\u00e9rale (VC) inexistante et une probabilit\u00e9 de r\u00e9pondre au traitement par la valve Zephyr\u00ae<\/sup> avec l\u2019aide du syst\u00e8me Chartis, ont \u00e9t\u00e9 randomis\u00e9s selon un rapport 1:1 soit dans le groupe trait\u00e9 par la valve Zephyr, soit dans le groupe recevant une prise en charge m\u00e9dicale standard.<\/li>\n
  • Les principales mesures des r\u00e9sultats comprenaient les diff\u00e9rences observ\u00e9es entre les groupes en termes de VEMS1<\/sub>, de CVF et de r\u00e9sultats au test de marche de 6 minutes (TM6) entre le d\u00e9but de l\u2019\u00e9tude et le 6e mois.<\/li>\n<\/ul> <\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n
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    Conception de l\u2019\u00e9tude<\/h2> <\/div>\n<\/div>\n\n
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    \n \"STELVIO \n <\/div>\n \n \n <\/div>\n\n
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    * L\u2019essai STELVIO est un essai qui a \u00e9t\u00e9 r\u00e9alis\u00e9 \u00e0 l\u2019initiative d\u2019un m\u00e9decin ind\u00e9pendant. L\u2019entreprise Pulmonx n\u2019a \u00e9t\u00e9 impliqu\u00e9e dans aucune partie de l\u2019\u00e9tude.<\/p>\n <\/div>\n<\/div>\n\n

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    R\u00e9sultats<\/h2> <\/div>\n<\/div>\n <\/div>\n <\/div>\n
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    Principaux crit\u00e8res d\u2019\u00e9valuation dans l\u2019intention de traiter la population<\/h4>\n

    Variation moyenne entre le d\u00e9but de l\u2019\u00e9tude et le 6e mois<\/p> <\/div>\n<\/div>\n <\/div>\n

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    VEMS1<\/sub><\/h5>\n

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Variation moyenne par rapport au d\u00e9but de l\u2019\u00e9tude.<\/p> <\/div>\n<\/div>\n<!-- \/module text --><!-- module text -->\n<div class=\"module module-text tb_f26i346 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n \n<table id=\"tablepress-24\" class=\"tablepress tablepress-id-24 stelvio\">\n<tbody class=\"row-striping\">\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\">Emphys\u00e8me Homog\u00e8ne (n=29)<\/td><td class=\"column-3\">Emphys\u00e8me h\u00e9t\u00e9rog\u00e8ne (n=22)<\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\">VEMS<sub>1<\/sub><\/td><td class=\"column-2\">+20,1<\/td><td class=\"column-3\">+32,6<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">VR (%)<\/td><td class=\"column-2\">-16,3<\/td><td class=\"column-3\">-16,6<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">TM6 (m\u00e8tres)<\/td><td class=\"column-2\">+69<\/td><td class=\"column-3\">+72<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">Score QRSG (points)<\/td><td class=\"column-2\">-13<\/td><td class=\"column-3\">-19<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n <\/div>\n<\/div>\n<!-- \/module text --><!-- module text -->\n<div class=\"module module-text tb_xhsd472 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h3 class=\"p1\">Des taux de r\u00e9ponses consid\u00e9rablement plus \u00e9lev\u00e9s ont \u00e9t\u00e9 observ\u00e9s chez les patients trait\u00e9s par la valve Zephyr par rapport aux patients recevant une prise en charge m\u00e9dicale standard<\/h3>\n<p class=\"p2\">R\u00e9sultats (DMCI) concernant la proportion de patients ayant termin\u00e9 l\u2019\u00e9tude et qui ont atteint une r\u00e9ponse.<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_4 tb_ojvn222\">\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_akwx224 first\">\n <!-- module text -->\n<div class=\"module module-text tb_l2lp137 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <p class=\"p1\">Variations dans le VEMS<span class=\"s1\"><sub>1<\/sub><\/span> <\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_gqfc225\">\n <!-- module text -->\n<div class=\"module module-text tb_vi93559 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Groupe t\u00e9moin<br>n=33<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_r15u364 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n \t<!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>STELVIO Study Page - French: STELVIO - FEV1 - Control Group | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" 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id=\"french-stelvio-page-fev1-crossover\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --> <\/div>\n <\/div>\n <div data-lazy=\"1\" class=\"module_subrow themify_builder_sub_row tf_w col_align_top tb_col_count_4 tb_3uxs997\">\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_uy3s998 first\">\n <!-- module text -->\n<div class=\"module module-text tb_7cpn999 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <p class=\"p1\">Variation dans le TM6<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_x11u999\">\n <!-- module text -->\n<div class=\"module module-text tb_2si50 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Groupe t\u00e9moin<br>n=33<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_m63841 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>STELVIO Study Page - French: STELVIO - 6MWD - Control Group | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code -->\r\n\t\t<script type=\"text\/javascript\">\r\n\t\t\tAmCharts.makeChart(\"french-stelvio-page-6mwd-control-group\",\r\n\t\t\t\t{\r\n \t\t\"hideCredits\": \"true\",\r\n\t\t\t\t\t\"type\": \"serial\",\r\n\t\t\t\t\t\"categoryField\": \"category\",\r\n\t\t\t\t\t\"autoMarginOffset\": 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center;\">Groupe trait\u00e9 par la valve Zephyr<br>n=25<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_s7o4650 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>STELVIO Study Page - French: STELVIO - 6MWD - Zephyr Valve | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code -->\r\n\t\t<script 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\"#4F2D7F\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"\",\r\n\t\t\t\t\t\t\t\"column-1\": \"220\",\r\n\t\t\t\t\t\t\t\"Color\": \"#4F2D7F\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"\",\r\n\t\t\t\t\t\t\t\"column-1\": \"233\",\r\n\t\t\t\t\t\t\t\"Color\": \"#4F2D7F\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t]\r\n\t\t\t\t}\r\n\t\t\t);\r\n\t\t<\/script>\r\n\t<\/head>\r\n\t<body>\r\n\t\t<div id=\"french-stelvio-page-6mwd-zephyr-valve\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_5aw80 last\">\n <!-- module text -->\n<div class=\"module module-text tb_l00m1 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Groupe pass\u00e9 en crossover au traitement par la valve Z\u00e9phyr<br>n=26<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_aq8q777 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>STELVIO Study Page - French: STELVIO - 6MWD - Crossover | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code -->\r\n\t\t<script type=\"text\/javascript\">\r\n\t\t\tAmCharts.makeChart(\"french-stelvio-page-6mwd-crossover\",\r\n\t\t\t\t{\r\n \t\t\"hideCredits\": \"true\",\r\n\t\t\t\t\t\"type\": \"serial\",\r\n\t\t\t\t\t\"categoryField\": 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data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_ouuy589 first\">\n <!-- module text -->\n<div class=\"module module-text tb_n5mf334 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <p class=\"p1\">Variation du score QRSG<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_ye4z590\">\n <!-- module text -->\n<div class=\"module module-text tb_jufa590 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Groupe t\u00e9moin<br>n=33<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_bgw7256 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>STELVIO STUDY - French: STELVIO - SGRQ - Control Group | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources 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#FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col4-1 tb_5re9590\">\n <!-- module text -->\n<div class=\"module module-text tb_86n1590 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center;\">Groupe trait\u00e9 par la valve Zephyr<br>n=25<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_0oto749 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>STELVIO STUDY - French: STELVIO - SGRQ - Zephyr Valve | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" 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10px;margin-bottom: 40px;\" data-lazy=\"1\">\n <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div class=\"module module-text tb_u6r8619 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h2 class=\"p1\">Conclusion<\/h2>\n<p class=\"p1\">Le traitement par valve endobronchique Zephyr<sup>\u00ae<\/sup> a am\u00e9lior\u00e9 significativement la fonction pulmonaire et la capacit\u00e9 \u00e0 faire de l\u2019exercice chez des patients pr\u00e9sentant un emphys\u00e8me s\u00e9v\u00e8re, et caract\u00e9ris\u00e9s par une absence de ventilation collat\u00e9rale interlobaire.<\/p>\n<p>Les complications du traitement par valve endobronchique Zephyr peuvent notamment comprendre un pneumothorax, une aggravation des sympt\u00f4mes de BPCO, une h\u00e9moptysie, une pneumonie, une dyspn\u00e9e et, dans de rares cas, la mort.<\/p>\n <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<!--\/themify_builder_content-->","protected":false},"excerpt":{"rendered":"<p>Une \u00e9tude multicentrique, multinationale, randomis\u00e9e et contr\u00f4l\u00e9e \u00e9valuant les valves endobronchiques Zephyr\u00ae chez des patients atteints d\u2019emphys\u00e8me h\u00e9t\u00e9rog\u00e8ne et pr\u00e9sentant une ventilation collat\u00e9rale faible ou inexistante.<\/p>\n","protected":false},"author":2,"featured_media":75917,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[54],"tags":[],"class_list":["post-75473","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-preuves-cliniques","has-post-title","has-post-date","has-post-category","has-post-tag","has-post-comment","has-post-author",""],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ 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