[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480764":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":48,"responsibleParty":66,"collaborators":42,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":42,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":93,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Biotronik AG","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Freesolve RMS","EXPERIMENTAL","Intervention with a Freesolve Sirolimus Eluting Resorbable Coronary Magnesium Scaffold System",[13],"Device: Freesolve RMS",{"label":15,"type":16,"description":17,"interventionNames":18},"Xience DES","ACTIVE_COMPARATOR","Intervention with a Xience Everolimus Eluting Stent System",[19],"Device: Xience DES",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Subject undergoes implantation of Freesolve RMS",[9],[26],"DREAMS 3G Sirolimus Eluting Resorbable Coronary Magnesium Scaffold System",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Subject undergoes implantation of Xience DES",[15],[31],"Xience Everolimus Eluting Stent System",[33],{"name":34,"affiliation":35,"role":36},"Michael Haude, MD","Rheinland Klinikum Neuss GmbH Lukaskrankenhaus Neuss","PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Barbara Widmann, PhD","CONTACT","0041 75 429 5530",null,"barbara.widmann@teleflex.com",{"name":45,"role":40,"phone":46,"phoneExt":42,"email":47},"Nadine Kluser","0041 75 429 54 82","nadine.kluser@teleflex.com",[49],{"facility":35,"status":50,"city":51,"state":42,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"RECRUITING","Neuss","41464","Germany","DE",{"type":56,"coordinates":57},"Point",[58,59],6.68504,51.19807,{"lat":59,"lon":58},[62],{"name":63,"role":40,"phone":64,"phoneExt":42,"email":65},"Michael Haude, Prof. Dr.","+49 2131 888 2000","michael.haude@rheinlandklinikum.de",{"type":67,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100480764","safety-and-clinical-performance-of-the-freesolve-resorbable-magnesium-scaffold-system-100480764",false,"NCT05540223","Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System","BIOTRONIK - Safety and Clinical Performance of the Drug Eluting Resorbable Coronary Magnesium Scaffold System (Freesolve®) in the Treatment of Subjects With de Novo Lesions in Native Coronary Arteries: BIOMAG-II: A Randomized Controlled Trial","BIOMAG-II","Clinical Inclusion Criteria:\n\n1. Subject is ≥ 18 years and ≤ 80 years of age\n2. Subject has provided written informed consent as approved by the Independent Ethical Committee (IEC) or Institutional Review Board (IRB) of the respective clinical site prior to the study related procedures\n3. Subject is eligible for PCI according to the applicable guidelines\n4. Subject is an acceptable candidate for coronary artery bypass surgery\n5. Subjects with stable or unstable angina pectoris, documented silent ischemia\u002Fabnormal physiologic testing or hemodynamically stable non-ST elevation myocardial infarction (NSTEMI) patients without angiographic evidence of thrombus at target lesion\n\n   Note: STEMI patients may be eligible for the study for treatment of selected non-culprit lesions, if:\n   * Subject and target lesion(s) meet all inclusion and no exclusion criteria and consent occurs at least ≥ 72 hours after successful treatment of the culprit lesion(s) \\[lesion(s) causing the acute STEMI\\];\n   * Subject is hemodynamically stable with documented declining cardiac biomarkers;\n   * Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s)\n6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine\n7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization)\n8. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study\n\nAngiographic Inclusion Criteria:\n\n1. Subjects with a maximum of two single de novo target lesions each in separate native coronary arteries\n2. Target vessel must have a reference diameter between 2.5-4.2 mm by visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) \u002F Intravascular Ultrasound (IVUS) \u002F Optical Coherence Tomography (OCT)\n3. Target lesion must be ≤28mm in length by operator visual estimation, which may be assissted by QCA \u002F IVUS \u002F OCT, (or \\\u003C 20 mm for target lesion(s) to be treated with a study device \\\u003C 3.0 mm in diameter) and should be amenable to treatment with a single study device\n4. Target lesion stenosis ≥ 50% and \\\u003C 100% by operator visual estimation, which may be assisted by QCA \u002F IVUS \u002F OCT. Target lesion stenosis \\\u003C 70% by visual estimation, should have clinical justification for treatment as per local standards.\n5. Target lesion must have a Thrombolysis In Myocardial Infarction (TIMI) flow ≥1\n\nClinical Exclusion Criteria:\n\n1. Subject is pregnant and\u002For breastfeeding or intends to become pregnant during the duration of the study\n2. Subject has clinical symptoms and\u002For electrocardiogram (ECG) changes consistent with STEMI \\\u003C 72 hours prior to the index procedure.\n\n   Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.\n3. Subject has undergone prior PCI within the target vessel during the last 12 months prior to the index procedure or prior PCI within a non-target vessel \\\u003C72 hours prior to the index procedure if successful and uncomplicated\n4. Subject is on dialysis or with impaired renal function (serum creatinine \\> 2.5 mg\u002FdL or 221 µmol\u002FL, determined within 72 hours prior to the index procedure)\n5. Subject has a known allergy to contrast medium that cannot be adequately premedicated, or any known allergy to aspirin, P2Y12 inhibitors, both heparin and bivalirudin, sirolimus, everolimus (or similar limus drugs), poly L-lactide, the scaffold material (magnesium, aluminium, tantalum), or Xience stent material (cobalt, chromium, tungsten, nickel, -methacrylic polymer, and fluoropolymer)\n6. Subject is receiving oral or intravenous immunosuppressive therapy (inhaled steroids are permitted) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus, systemic lupus erythematosus; diabetes mellitus is permitted)\n7. Life expectancy less than 1 year\n8. Planned surgery or dental surgical procedure within 6 months after index procedure, unless DAPT can be maintained\n9. In the investigator's opinion subject will not be able to comply with the follow-up requirements\n10. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained for a minimum of 1 month\n11. Subject has had a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure\n12. Subject with active bleeding disorder, active coagulopathy, or any other reason, who is ineligible for DAPT\n13. Subject is currently participating or plans to participate in another study with an investigational device or an investigational drug\n\nAngiographic Exclusion Criteria:\n\n1. Target vessel has been previously treated and the target lesion is within 5 mm proximal or distal to the previously treated lesion\n2. Left main coronary artery disease\n3. Target lesion was totally occluded (100% stenosis)\n4. Thrombus in target vessel\n5. Future planned staged PCI either in target or non-target vessel\n6. Ostial target lesion within the left descending (LAD), left circumflex (LCx), or right coronary artery (within 5.0 mm of vessel origin)\n7. Target lesion involves a side branch ≥ 2.0 mm in diameter that requires a two-device strategy after pre-dilatation\n8. Target lesion is located in or supplied by an arterial or venous bypass graft\n9. Target lesion with excessive tortuosity proximal to or within the lesion based on visual estimation or heavily calcified target lesion which cannot be adequately pre-dilated by a non-compliant and\u002For cutting\u002Fscoring balloon as described in angiographic exclusion criteria 10.\n10. The target lesion requires treatment with the device other than the non-compliant balloon and\u002For cutting\u002Fscoring balloon prior to scaffold\u002Fstent placement (including but not limited to atherectomy devices, intravascular lithotripsy, drug-coated balloons etc.)\n11. Target vessel was treated with brachytherapy any time prior to the index procedure.\n12. Unsuccessful pre-dilatation, defined as residual stenosis \\> 20% (by visual estimation) and \u002F or angiographic complications (e.g. distal embolization, side branch closure, flow-limiting dissections)","ALL","18 Years","80 Years",{"count":80,"type":81},1859,"ESTIMATED","INTERVENTIONAL",[84],"NA","The objective of this study is to assess the safety and efficacy of the Freesolve in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to a contemporary drug eluting stent (DES).",[87,88,89,90,91,92],"Coronary Artery Disease","Atherosclerosis, Coronary","Myocardial Ischemia","Ischemic Heart Disease","Acute Coronary Syndrome","Angina Pectoris",[94,95,96,97],"Resorbable Magnesium Scaffold","Sirolimus","RMS","Drug eluting absorbable metal scaffold","2025-11-18",{"date":100,"type":101},"2025-11-21","ACTUAL",{"date":103,"type":101},"2024-05-13",{"date":105,"type":81},"2032-02",{"name":5,"class":6},1]