[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07258290":3,"trial-entities:NCT07258290":141,"trial-summary:NCT07258290":146},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":34,"study_type":39,"primary_purpose":40,"phases":41,"enrollment_info":43,"interventions":46,"primary_outcomes":56,"secondary_outcomes":61,"sex":101,"minimum_age":102,"maximum_age":103,"healthy_volunteers":104,"eligibility_criteria":105,"std_ages":111,"locations":114,"central_contacts":132,"overall_officials":138,"references":139,"see_also_links":140},"NCT07258290","G230176","Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold (RMS) System in Subjects With Coronary Artery Lesions","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","RECRUITING","2033-06","2025-11","2026-07-24","2026-06-11","Teleflex","INDUSTRY",true,"The objective of this study is to assess the safety and efficacy of the Freesolve resorbable magnesium scaffold (RMS) in the treatment of subjects with up to two de novo lesions in native coronary arteries compared to the Xience coronary drug-eluting stent (DES) system","The BIOMAG-III clinical trial is a prospective, international, multi-center, single-blinded, randomized controlled, non-inferiority trial to compare the Freesolve Sirolimus Eluting Coronary Resorbable Magnesium Scaffold (Freesolve RMS) System with the Xience Everolimus Eluting Stent (Xience DES) System. with respect to Target Lesion Failure (TLF) rate at 12 months. Subjects will be randomized in a 2:1 fashion Freesolve to Xience. A total of up to 1859 subjects will be randomized at up to 120 total sites worldwide including North America, Europe, and Asia Pacific. Clinical follow-up will be conducted at 1, 6, and 12 months and at 2, 3, 4, and 5 years post-procedure.",[19,20,21,22,23,24,25,26,27,28,29,30,31,32,33],"Coronary Disease","Heart Diseases","Cardiovascular Diseases","Arteriosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Chest Pain","Pain","Neurologic Manifestations","Signs and Symptoms","Pathological Conditions, Signs and Symptoms","Coronary Artery Disease","Myocardial Ischemia","Acute Coronary Syndrome","Angina Pectoris",[35,36,37,38],"Resorbable Magnesium Scaffold","Sirolimus","RMS","Drug eluting absorbable metal scaffold","INTERVENTIONAL","TREATMENT",[42],"NA",{"count":44,"type":45},1859,"ESTIMATED",[47,52],{"type":48,"name":49,"description":50,"armGroupLabels":51},"DEVICE","Freesolve RMS","Freesolve Sirolimus-Eluting Coronary Resorbable Magnesium Scaffold (RMS) System, a drug-eluting balloon-expandable resorbable scaffold",[49],{"type":48,"name":53,"description":54,"armGroupLabels":55},"Xience DES","Xience Everolimus Eluting Stent System",[53],[57],{"measure":58,"description":59,"timeFrame":60},"Target Lesion Failure (TLF) rate at 12 months post-index procedure","The primary endpoint is Target Lesion Failure (TLF) at 12 months, a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven target lesion revascularization (TLR).","12 months",[62,66,69,73,77,79,81,83,85,87,89,91,93,97],{"measure":63,"description":64,"timeFrame":65},"Procedure success","Procedure success defined as achievement of \\\u003C 30% final residual diameter stenosis \\[by Quantitative Coronary Angiography (QCA) or visual estimation\\] of the target lesion using the assigned study device only, without the occurrence of cardiac death, Q-wave or non-Q-wave MI, or repeat revascularization of the target lesion during the hospital stay","Hospital Discharge (6-24 hours post-index procedure)",{"measure":67,"description":68,"timeFrame":65},"Device Success","Device Success defined as a final residual diameter stenosis of \\\u003C 30% by QCA or visual estimation, using the assigned device only with\n\n* successful delivery of the device to the target lesion, and\n* appropriate device deployment, and\n* successful removal of the delivery system",{"measure":70,"description":71,"timeFrame":72},"Target lesion failure (TLF)","TLF is defined as a composite of Cardiac Death, Target Vessel Q-wave or non-Q-wave myocardial infarction (MI), or clinically driven Target Lesion Revascularization (TLR)","Time Frame: 1, 6 months and 2, 3, 4 and 5 years post-index procedure",{"measure":74,"description":75,"timeFrame":76},"Target Vessel Failure (TVF)","Target Vessel Failure (TVF), a composite of Cardiac Death, Target Vessel Q-wave or non-Q wave MI, or clinically driven Target Vessel Revascularization (TVR)","1, 6, 12 months and 2, 3, 4 and 5 years post-index procedure",{"measure":78,"timeFrame":76},"Cardiac death",{"measure":80,"timeFrame":76},"Cardiovascular death",{"measure":82,"timeFrame":76},"All-cause mortality",{"measure":84,"timeFrame":76},"Target vessel MI in accordance with the primary endpoint definitions for periprocedural and non-periprocedural MI",{"measure":86,"timeFrame":76},"Any MI (including non-target vessel territory)",{"measure":88,"timeFrame":76},"Clinically driven TLR",{"measure":90,"timeFrame":76},"Clinically driven TVR",{"measure":92,"timeFrame":76},"Scaffold\u002Fstent thrombosis (definite, definite\u002Fprobable, probable) according to Academic Research Consortium (ARC-2) criteria for acute, sub-acute, late, very late and cumulative scaffold\u002Fstent thrombosis",{"measure":94,"description":95,"timeFrame":96},"Powered Secondary Endpoint 1: TLF from 1-5 Years","A powered secondary endpoint of cumulative TLF rates between 1 and 5 years post-procedure will be evaluated.","1 to 5 years post-index procedure",{"measure":98,"description":99,"timeFrame":100},"Powered Secondary Endpoint 2: TLF at 12 Months in the Diabetic Population","A powered secondary endpoint of TLF at 12 months in the diabetic population will be evaluated.","12 months post-index procedure","ALL","18 Years","80 Years",false,{"inclusion":106,"exclusion":109,"raw_text":110},[107,108],"Subject is hemodynamically stable with documented declining cardiac biomarkers;","Target lesion(s) to be treated are not located in the culprit vessel(s) and are not culprit lesion(s) 6. Subject is eligible for Dual Antiplatelet Therapy (DAPT) with aspirin plus either clopidogrel, prasugrel, ticagrelor or ticlopidine 7. Documented left ventricular ejection fraction (LVEF) ≥ 30% within 6 months prior to or during the procedure (prior to randomization) 8. Subject is willing and able to comply with protocol requirements, including completion of study visits for the duration of the study",[],"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 Ethics Committee \u002F 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 operator visual estimation, which may be assisted by Quantitative Coronary Angiography (QCA) \u002F Intravascular Ultrasound (IVUS) \u002F Optical Coherence Tomography (OCT)\n3. Target lesion(s) must be ≤ 36 mm in length by operator visual estimation, which may be assisted 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 must 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 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 \\\u003C 72 hours prior to the index procedure\n4. Subject is on dialysis or has impaired renal function (serum creatinine \\> 2.5 mg\u002FdL or 221 µmol\u002FL, determined within 7 days 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, aluminum, 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\n14. Subject has known severe aortic or mitral valve stenosis\u002Finsufficiency or has previously undergone transcatheter aortic valve replacement (TAVR)\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 is 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 anterior descending (LAD), left circumflex (LCX), or right coronary artery (RCA) (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. Target lesion requires treatment with a 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\u002For angiographic complications (e.g., distal embolization, side branch closure, flow-limiting dissections)",[112,113],"ADULT","OLDER_ADULT",[115,124],{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":120,"geoPoint":121},"MedStar Washington Hospital Center","Washington D.C.","District of Columbia","20010","United States",{"lat":122,"lon":123},38.89511,-77.03637,{"facility":125,"status":8,"city":126,"state":127,"zip":128,"country":120,"geoPoint":129},"Charleston Area Medical Center","Charleston","West Virginia","25304",{"lat":130,"lon":131},38.34982,-81.63262,[133],{"name":134,"role":135,"phone":136,"email":137},"BIOMAG-III Project Manager","CONTACT","1-866-246-6990","biomag_us@teleflex.com",[],[],[],{"nct_id":4,"conditions":142,"biomarkers":145},[32,143,30,144],"Angina","Ischemic Heart Disease",[],{"nct_id":4,"found":104,"summary":147,"prompt_version":147},null]