{"id":9346,"date":"2024-09-10T14:08:21","date_gmt":"2024-09-10T19:08:21","guid":{"rendered":"https:\/\/shockwavemedical.com\/education\/rollercoastr-epic22-trial-the-importance-of-device-selection\/"},"modified":"2025-05-30T13:28:56","modified_gmt":"2025-05-30T18:28:56","slug":"rollercoastr-epic22-trial-the-importance-of-device-selection","status":"publish","type":"post","link":"https:\/\/shockwavemedical.com\/de\/education\/rollercoastr-epic22-trial-the-importance-of-device-selection\/","title":{"rendered":"ROLLERCOASTR-EPIC22 Trial: the Importance of Device Selection"},"content":{"rendered":"\n<section id=\"block_32e01a4fe069cf36bf644cf9f162f383\" class=\"block block--wysiwyg wysiwyg_styles u-bgColorNone container\">\n\t<div class=\"u-wysiwyg u-animation\">\n\t\t<p>During this year\u2019s EuroPCR, Dr. Alfonso Jurado-Rom\u00e1n (La Paz University Hospital \u2013 Madrid, Spain) presented the results of <a href=\"https:\/\/shockwavemedical.com\/wp-content\/uploads\/2024\/11\/Trial_Summary_Visual_Branded_Revised-1.pdf\" target=\"_blank\" rel=\"noopener\">ROLLERCOASTR-EPIC22<\/a>, a prospective, randomized, controlled trial that filled the gap by adding randomized evidence and confirming the importance of device selection and their complementary nature.<\/p>\n<p><a href=\"https:\/\/shockwavemedical.com\/wp-content\/uploads\/2024\/11\/Trial_Summary_Visual_Branded_Revised-1.pdf\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" class=\"aligncenter wp-image-9324 size-full lazyload\" data-src=\"https:\/\/shockwavemedical.com\/wp-content\/uploads\/2024\/11\/Trial_Summary_Visual_Branded_Revised.webp\" alt=\"\" width=\"508\" height=\"718\" data-srcset=\"https:\/\/shockwavemedical.com\/wp-content\/uploads\/2024\/11\/Trial_Summary_Visual_Branded_Revised.webp 508w, https:\/\/shockwavemedical.com\/wp-content\/uploads\/2024\/11\/Trial_Summary_Visual_Branded_Revised-212x300.webp 212w\" data-sizes=\"(max-width: 508px) 100vw, 508px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 508px; --smush-placeholder-aspect-ratio: 508\/718;\" \/><\/a><\/p>\n\t<\/div>\n\t<\/section>\n\n\n<section id=\"block_b7808a3749f32047d013ad40a2b887ce\" class=\"block block--wysiwyg wysiwyg_styles u-bgColorNone container\">\n\t<div class=\"u-wysiwyg u-animation\">\n\t\t<p>The study compared safety and efficacy of IVL, RA and ELCA in PCI on moderate and severe calcified lesion. The results showed similar success rate, MSA and stent expansion across all arms. Shockwave IVL proved once again its safety profile, reporting 0% severe procedural complications\u00a0(includes death, perforation, flow-limiting dissection, abrupt vessel closure, ST)\u00a0in the IVL arm.<\/p>\n<p><span data-teams=\"true\"><span dir=\"ltr\"><strong>Don\u2019t miss the interview with Dr. Nick West and Dr. Alfonso Jurado-Rom\u00e1n discussing additional insights and learnings of this trial!<\/strong><\/span><\/span><\/p>\n<div class=\"video\"><iframe title=\"YouTube video player\" data-src=\"https:\/\/www.youtube.com\/embed\/GNEIImUgBIU?si=Q_8_O3P6AkiOS46g\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" class=\"lazyload\" data-load-mode=\"1\"><\/iframe><\/div>\n\t<\/div>\n\t<\/section>\n\n\n<section id=\"block_6af8cb0645f10b19530f06fd9011f6d1\" class=\"block block--wysiwyg wysiwyg_styles u-bgColorNone container\">\n\t<div class=\"u-wysiwyg u-animation\">\n\t\t<hr \/>\n<p><span class=\"legal_copy\">Dr Alfonso Jurado-Rom\u00e1n is a paid consultant for Shockwave Medical.\u00a0See Important Safety information below.<\/span><\/p>\n<p><span class=\"legal_copy\"><strong>Coronary IVL<\/strong><\/span><\/p>\n<p><span class=\"legal_copy\"><strong>Shockwave C2 and Shockwave C2+ Safety Information<\/strong><\/span><\/p>\n<p><span class=\"legal_copy\">In the United States: Rx only.<\/span><\/p>\n<p><span class=\"legal_copy\"><strong>Indications for Use \u2013<\/strong> The Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2 and C2+ Coronary IVL Catheter is indicated for lithotripsy-enabled, low-pressure balloon dilatation of severely calcified, stenotic de novo coronary arteries prior to stenting. <\/span><\/p>\n<p><span class=\"legal_copy\"><strong>Contraindications \u2013<\/strong> The Shockwave C2 and C2+ Coronary IVL System is contraindicated for the following: This device is not intended for stent delivery. This device is not intended for use in carotid or cerebrovascular arteries. <\/span><\/p>\n<p><span class=\"legal_copy\"><strong>Warnings \u2013<\/strong> Use the IVL Generator in accordance with recommended settings as stated in the Operator\u2019s Manual. The risk of a dissection or perforation is increased in severely calcified lesions undergoing percutaneous treatment, including IVL. Appropriate provisional interventions should be readily available. Balloon loss of pressure was associated with a numerical increase in dissection which was not statistically significant and was not associated with MACE. Analysis indicates calcium length is a predictor of dissection and balloon loss of pressure. IVL generates mechanical pulses which may cause atrial or ventricular capture in bradycardic patients. In patients with implantable pacemakers and defibrillators, the asynchronous capture may interact with the sensing capabilities. Monitoring of the electrocardiographic rhythm and continuous arterial pressure during IVL treatment is required. In the event of clinically significant hemodynamic effects, temporarily cease delivery of IVL therapy. <\/span><\/p>\n<p><span class=\"legal_copy\"><strong>Precautions \u2013<\/strong> Only to be used by physicians trained in angiography and intravascular coronary procedures. Use only the recommended balloon inflation medium. Hydrophilic coating to be wet only with normal saline or water and care must be taken with sharp objects to avoid damage to the hydrophilic coating. Appropriate anticoagulant therapy should be administered by the physician. Precaution should be taken when treating patients with previous stenting within 5mm of target lesion. <\/span><\/p>\n<p><span class=\"legal_copy\">Potential adverse effects consistent with standard based cardiac interventions include- Abrupt vessel closure \u2013 Allergic reaction to contrast medium, anticoagulant and\/or antithrombotic therapy-Aneurysm-Arrhythmia-Arteriovenous fistula-Bleeding complications-Cardiac tamponade or pericardial effusion-Cardiopulmonary arrest-Cerebrovascular accident (CVA)-Coronary artery\/vessel occlusion, perforation, rupture or dissection-Coronary artery spasm-Death-Emboli (air, tissue, thrombus or atherosclerotic emboli)-Emergency or nonemergency coronary artery bypass surgery-Emergency or nonemergency percutaneous coronary intervention-Entry site complications-Fracture of the guide wire or failure\/malfunction of any component of the device that may or may not lead to device embolism, dissection, serious injury or surgical intervention-Hematoma at the vascular access site(s)- Hemorrhage-Hypertension\/Hypotension-Infection\/sepsis\/fever-Myocardial Infarction-Myocardial Ischemia or unstable angina-Pain-Peripheral Ischemia-Pseudoaneurysm-Renal failure\/insufficiency-Restenosis of the treated coronary artery leading to revascularization-Shock\/pulmonary edema-Slow flow, no reflow, or abrupt closure of coronary artery-Stroke Thrombus-Vessel closure, abrupt-Vessel injury requiring surgical repair-Vessel dissection, perforation, rupture, or spasm. <\/span><\/p>\n<p><span class=\"legal_copy\">Risks identified as related to the device and its use: Allergic\/immunologic reaction to the catheter material(s) or coating-Device malfunction, failure, or balloon loss of pressure leading to device embolism, dissection, serious injury or surgical intervention-Atrial or ventricular extrasystole-Atrial or ventricular capture. <\/span><\/p>\n<p><span class=\"legal_copy\">Prior to use, please reference the Instructions for Use for more information on indications, contraindications, warnings, precautions and adverse events. www.shockwavemedical.com\/IFU. <\/span><\/p>\n\t<\/div>\n\t<\/section>","protected":false},"excerpt":{"rendered":"<p>During this year\u2019s EuroPCR, Dr Alfonso Jurado-Rom\u00e1n presented the results of ROLLERCOASTR-EPIC22, confirming the importance of device selection.<\/p>\n","protected":false},"author":14,"featured_media":3721,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":[207,210],"meta":{"_acf_changed":true,"content-type":"","footnotes":""},"categories":[3],"tags":[],"disease-state":[161],"education-topic":[431],"product-tag":[257,253],"specialty":[297,330,334,346],"technology":[318],"class_list":["post-9346","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-unkategorisiert","disease-state-coronary-artery-disease-de","education-topic-clinical-evidence-de","format-article-de","format-video-de","product-tag-shockwave-c2-de-2","product-tag-shockwave-c2-de","specialty-fellows-residents-de","specialty-interventional-cardiologists-de","specialty-interventional-radiologists-de","specialty-vascular-surgeons-de","technology-coronary-ivl-de"],"acf":[],"_links":{"self":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts\/9346","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/users\/14"}],"replies":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/comments?post=9346"}],"version-history":[{"count":0,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/posts\/9346\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/media\/3721"}],"wp:attachment":[{"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/media?parent=9346"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/categories?post=9346"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/tags?post=9346"},{"taxonomy":"disease-state","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/disease-state?post=9346"},{"taxonomy":"education-topic","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/education-topic?post=9346"},{"taxonomy":"format","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/format?post=9346"},{"taxonomy":"product-tag","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/product-tag?post=9346"},{"taxonomy":"specialty","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/specialty?post=9346"},{"taxonomy":"technology","embeddable":true,"href":"https:\/\/shockwavemedical.com\/de\/wp-json\/wp\/v2\/technology?post=9346"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}