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Baan","J. Baan, MD, PhD",[102],{"name":103,"class":104},"B. Braun Medical B.V.","INDUSTRY","100142662","dare-trial-a-trial-studying-the-effect-of-the-sequent-please-drug-eluting-balloon-compared-to-the-xience-prime-drug-eluting-stent-for-the-treatment-of-stenosis-of-an-earlier-implanted-stent-100142662",false,"NCT01127958","DARE-trial: A Trial Studying the Effect of the SeQuent Please Drug-eluting Balloon Compared to the Xience Prime Drug-eluting Stent for the Treatment of Stenosis of an Earlier Implanted Stent.","DARE-Trial: Drug Eluting bAlloon for In-stent REstenosis. Multi-center, Randomized Trial to Study the Effect of the SeQuent Please Drug-eluting Balloon Versus the Xience Prime Drug-eluting Stent for the Treatment of In-stent Restenosis.","Inclusion Criteria:\n\n* Restenosis of the initially stented main vessel, including ostial, left main and bifurcation lesions as well as venous or arterial grafts\n* Restenosis of any type of stent; all drug-eluting stents or bare metal stents\n* Restenosis must be present \\> 50% in-stent and \\\u003C 5 mm out of the stent\n* A reference diameter of ≥ 2.0 to 4.0 millimeters by visual estimation\n* Amendable to PCI treatment with either the SeQuent ® Please DEB or the Xience™ Prime DES\n* Amendable to dual antiplatelet treatment for the duration of 1 year\n* Patients must be ≥ 18 years of age\n* Patients must be able to understand the aim of the study, including risks, benefits and treatment alternatives\n* Patients must agree to undergo a follow-up angiogram at 6 months (± 1 month)\n* Patients must agree to undergo a clinical follow-up at 30 days, 6 months, 1, 2, 3, 4, and 5 years\n\nExclusion Criteria:\n\n* The impossibility to arrange a follow-up coronary angiography at 6 months (± 1 month) after baseline procedure is considered an exclusion criterion for this study\n* Patients have to meet the inclusion criteria;\n* Life expectancy less than one year\n* Severe renal insufficiency (glomerular filtration rate \\\u003C30mL\u002Fmin), with exception of of patients with renal dialysis\n* STEMI\n* Restenosis in a biodegradable stent\n* Restenosis in a non CE marked stent\n* Requirement for PCI in the same vessel or expected in the next 6 months","ALL","18 Years",{"count":115,"type":116},270,"ACTUAL","INTERVENTIONAL",[119],"NA","The main objective of the study is to determine whether PCI for in-stent restenosis with a drug eluting balloon is angiographically non-inferior to PCI with a drug eluting stent at 6 month follow up.",[122],"In-stent Restenosis",[124,125,126,127],"In-stent restenosis","Minimal lumen diameter","Drug eluting balloon","Drug eluting stent","UNKNOWN","2017-02-16",{"date":131,"type":116},"2017-02-17",{"date":133,"type":25},"2010-05",{"date":135,"type":136},"2020-06","ESTIMATED",{"name":5,"class":6},8]