[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Teleflex\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":110},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,61,88],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":43,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100612800","safety-and-clinical-performance-of-the-freesolve-resorbable-magnesium-scaffold-rms-system-in-subjects-with-coronary-artery-lesions-100612800",false,"NCT07258290","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","BIOMAG-III","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)","ALL","18 Years","80 Years",{"count":21,"type":22},1859,"ESTIMATED","INTERVENTIONAL",[25],"NA","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",[28,29,30,31,32,33,34,35,36,37,38,39,40,41,42],"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",[44,45,46,47],"Resorbable Magnesium Scaffold","Sirolimus","RMS","Drug eluting absorbable metal scaffold","RECRUITING","2026-06-15",{"date":51,"type":52},"2026-06-17","ACTUAL",{"date":54,"type":52},"2026-06-11",{"date":56,"type":22},"2033-06",{"name":58,"class":59},"Teleflex","INDUSTRY",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":23,"phases":71,"briefSummary":72,"conditions":73,"keywords":74,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},"100576003","safety-and-effectiveness-of-the-orsiro-mission-48-mm-sirolimus-eluting-coronary-stent-system-in-subjects-with-coronary-artery-lesions-100576003","NCT06779630","Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus Eluting Coronary Stent System in Subjects With Coronary Artery Lesions","A Prospective Multicenter Single Arm Study to Assess the Safety and Effectiveness of the Orsiro Mission 48-mm Sirolimus-Eluting Coronary Stent System for the Treatment of Subjects With Atherosclerotic Lesion(s)","BIOFLOW-48","Inclusion Criteria:\n\n1. Subject is ≥ 18 years of age\n2. Subject is able to understand the nature of the study and provide written informed consent.\n\n   For sites outside of the United States: Note: For subjects presenting with STEMI and not in a position to read, interpret and sign the informed consent form, oral informed consent is required.\n3. Subject is an acceptable candidate for percutaneous coronary intervention (PCI) according to the applicable guidelines.\n4. Subject is an acceptable candidate for CABG.\n5. Subject is eligible for dual antiplatelet therapy (DAPT) according to guidelines.\n6. Subject has clinical evidence of ischemic heart disease, stable or unstable angina pectoris or documented silent ischemia.\n7. Subject is willing and able to comply with study follow-up requirements.\n\nAngiographic inclusion criteria:\n\n1. Subject has only one target lesion in a native coronary artery to be treated with the investigational device.\n\n   Note: One additional non-target lesion may be treated with a non-investigational treatment (e.g. stent, balloon angioplasty, atherectomy) with the exception of brachytherapy, if it is located in a different coronary artery. The non-target lesion must be treated first and must be deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis \\\u003C 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.)\n\n   Note: Multiple focal stenoses will be considered as a single lesion if they are amenable to treatment with a single study device.\n2. Target lesion must be \\> 36 mm and ≤ 44 mm in length by operator visual estimate and must be amenable to treatment with a single study device.\n3. Target vessel must have a reference vessel diameter of 2.25-4.0 mm by operator visual estimate.\n4. For sites in United States: Target lesion must be de novo or restenotic lesion in native coronary artery; restenotic lesion must have been treated with a standard PTCA only.\n\n   For sites outside of the United States: Target lesion can be de novo, restenotic or in-stent restenotic, and must be located in a native coronary artery.\n5. Target lesion must have angiographic evidence of ≥ 50% and \\\u003C 100% stenosis (by operator visual estimate which may be assisted by QCA \u002F IVUS \u002F OCT). Target lesion stenosis \\\u003C 70% should have clinical justification for treatment as per local standards.\n6. Target vessel must have a Thrombolysis In Myocardial Infarction (TIMI) flow \\> 1.\n\nFor sites outside of the United States: Note: For STEMI, TIMI flow \\> 1 prior to stent implantation (after opening the vessel with a guide wire or a balloon).\n\nExclusion Criteria:\n\n1. For sites in United States only: Subject has clinical symptoms and\u002For electrocardiogram (ECG) changes consistent with acute ST elevation myocardial infarction (STEMI) within 72 hours prior to the index procedure.\n\n   Note: Hemodynamically stable non-STEMI (NSTEMI) subjects are eligible for study enrollment.\n2. Subject is hemodynamically unstable.\n3. Subject is pregnant and\u002For breastfeeding or intends to become pregnant during the duration of the study.\n4. Subject has a known allergy to contrast medium that cannot be adequately pre-medicated, or any known allergy to thienopyridine, aspirin, both heparin and bivalirudin, L-605 cobalt-chromium (Co-Cr) alloy or one of its major elements (cobalt, chromium, tungsten and nickel), acrylic, fluoropolymers, silicon carbide, PLLA or sirolimus.\n5. Revascularization of any target vessel within 12 months prior to the index procedure or previous PCI of any non-target vessel within \\\u003C72 hours prior to the index procedure.\n6. Future planned PCI (including staged procedure) or CABG after the index procedure.\n7. Planned surgery or dental surgical procedure within 6 months of index procedure unless dual antiplatelet therapy can be maintained throughout the peri-surgical period.\n8. History of a stroke or transient ischemic attack (TIA) within 6 months prior to the index procedure.\n9. Subjects with active bleeding disorders, active coagulopathy, or any other reason, who are ineligible for DAPT.\n10. Subject will refuse blood transfusions.\n11. Subject has a left ventricular ejection fraction (LVEF) \\\u003C 30% within 6 months prior to or during the index procedure that was documented by any method.\n12. Subject is dialysis dependent or has impaired renal function (i.e., serum creatinine \\> 2.5 mg\u002FdL or 221 µmol\u002FL, determined within 7 days prior to the index procedure).\n13. Subject has a documented white blood cell count \\\u003C 3,000 white blood cells\u002Fmm3 or a documented platelet count \\\u003C 100,000 platelets\u002Fmm3 or \\> 700,000 platelets\u002Fmm3.\n14. 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).\n15. Subject is receiving or scheduled to receive chemotherapy within 30 days before or after the index procedure or has a malignancy that is not in remission.\n16. Subjects under oral anticoagulation therapy (OAC) prior to index procedure unless DAPT + OAC (i.e. triple therapy) can be maintained according to guidelines.\n17. Subject has life expectancy of \\\u003C 1 year.\n18. Subject is currently participating or plans to participate in another clinical investigation with an investigational device or an investigational drug.\n19. In the investigator's opinion, subject will not be able to comply with the follow-up requirements.\n\nAngiographic exclusion criteria:\n\n1. Target lesion is excluded if it meets any of the following criteria:\n\n   1. Lesion is located within or treated through a saphenous vein graft or arterial graft.\n   2. Lesion location is within the left main coronary artery.\n   3. Lesion location is within 3 mm of the origin of the left anterior descending (LAD) or left circumflex (LCX) coronary arteries.\n   4. Involves a side branch of \\> 2.0 mm in diameter that requires a two-device strategy after pre-dilatation.\n   5. Lesion is totally occluded (100% stenosis).\n   6. For sites in United States only: Lesion is a restenotic lesion that was previously treated with a bare metal or drug eluting stent (in-stent restenosis).\n2. Target vessel\u002Flesion is excessively tortuous\u002Fangulated or is severely calcified, that would prevent complete inflation of an angioplasty balloon. This assessment should be based on visual estimation.\n3. Site sites in the United States: Target vessel has angiographic evidence of thrombus.\n\n   For sites outside of the United States: Target vessel has angiographic evidence of unresolved large thrombus burden despite of thrombus aspiration.\n\n   Note: Thrombus aspiration is left at the discretion of the implanting physician.\n4. Target vessel was treated with brachytherapy any time prior to the index procedure.\n5. Unsuccessful target lesion pre-dilatation, defined as residual stenosis \\> 50% (by visual estimation) and\u002For angiographic complications (e.g., distal embolization, side branch closure, dissection greater than National Heart, Lung, Blood Institute type C), and\u002For, for sites outside of the United States, coronary aneurysms.\n6. Non-target lesion is excluded if it meets any of the following criteria:\n\n   1. Any of the target lesion angiographic exclusion criteria except for 1c\n   2. Lesion is located within the target vessel.\n   3. Lesion is \\> 36 mm by operator visual estimate.\n   4. Lesion requires additional, unplanned stents to treat a complication.\n   5. Lesion treatment is not deemed an angiographic success. (Angiographic success is defined by a residual diameter stenosis \\\u003C 30% with TIMI 3 flow, as visually assessed by the physician, without the presence of prolonged chest pain or ECG changes consistent with MI.)",{"count":70,"type":22},150,[25],"The purpose of the study is to assess the safety and efficacy of the Orsiro® Mission 48- mm Sirolimus-Eluting Coronary Stent System in the treatment of subjects with atherosclerotic lesion(s) \\>36 mm and ≤ 44 mm in length (by visual estimate) in the native coronary arteries with a reference vessel diameter of 2.25 mm to 4.0 mm.\n\nPatients enrolled in the United States will be followed for 2 years post index procedure with follow-up visits at 1, 6, 12 months and 2 years post index procedure. Patients enrolled outside of the United States will be followed through 5 years post index procedure with additional follow-up visits at 3 and 5 years post index procedure.",[39],[75,76,77,78],"Orsiro Mission","Sirolimus-Eluting","Coronary Stent System","coronary artery disease","2026-06-02",{"date":81,"type":52},"2026-06-03",{"date":83,"type":52},"2025-07-18",{"date":85,"type":22},"2031-09",{"name":58,"class":59},20,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":5},"100562505","a-clinical-registry-to-demonstrate-the-safety-and-performance-of-teleflex-vascular-access-devices-100562505","NCT06604039","A Clinical Registry to Demonstrate the Safety and Performance of Teleflex Vascular Access Devices","A Prospective Clinical Registry Evaluating Safety and Performance of Teleflex Vascular Access Devices","VADER","Inclusion Criteria:\n\n* Subjects will undergo a procedure that will include use of a Teleflex device covered by this Research.\n* Subject is willing and capable of providing informed consent and\u002For give approval to collect, store and process limited health information by the Sponsor; or such consent is provided by a legally designated representative if required by local law or regulation.\n* Subjects is able to read and understand English or Spanish languages\n\nExclusion Criteria:\n\n* Subject is currently participating in another clinical Registry or investigation that may confound the results of this Registry.\n* Subject was previously failed screening or was enrolled in this clinical Registry.\n* Subject is imprisoned\n* Subject is cognitively impaired and unable to provide informed consent",{"count":97,"type":22},2500,"OBSERVATIONAL","The general objective of Teleflex's Vascular Access Device Registry (VADER) is to provide high-quality Level 3 (or better) data on the performance, safety and clinical benefits of Teleflex's vascular access devices when used in a real-world setting",[101],"Vascular Access Device","2025-08-01",{"date":104,"type":52},"2025-08-07",{"date":106,"type":52},"2024-12-08",{"date":108,"type":22},"2034-12-07",{"name":58,"class":59},""]