[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"American Heart of Poland\",\"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,[8,46,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100629555","poland-italy-aortic-research-bridge-real-world-registry-100629555",false,"NCT07476196","Poland-Italy Aortic Research Bridge Real World Registry","A Pragmatic, Observational, Multicenter Registry on the Implantation of the Tri Modular PERCUTEK Tycheseal™ Endograft System for the Treatment of Abdominal Aortic Aneurysm (AAA)","POWER","Anatomical Inclusion Criteria (as per IFU):\n\n* Morphologically suitable aneurysm\n* Neck length ≥ 10 mm\n* Neck diameter suitable for 20-36 mm body (considering 10-20% of oversizing)\n* Neck angle: infrarenal ≤ 75°\n* Distal seal zone ≥ 10 mm\n* Iliac arteries 8-20 mm diameter\n\nPatient Inclusion Criteria:\n\n* Age \\>18 years\n* Signed informed consent\n* Pregnancy test for premenopausal women\n\nExclusion Criteria:\n\n* Anatomical unsuitability\n* Subject has a life expectancy \\\u003C 1 year\n* Circumferential thrombus in neck\n* Ruptured aneurysm\n* Renal arteries from aneurysm sac\n* Dominant IMA with obstructed visceral vessels\n* Internal iliac artery aneurysms (unless pre-treated)\n* Subject has a known contraindication dual antiplatelets therapy or contrast media,\n* Selected patients with chronic kidney failure (CKF) can undergo EVAR using standard contrast or CO2 as contrast agent.\n* Previous aortoiliac surgery or EVAR\n* Recent stroke\u002FMI (\\\u003C 3 months)\n* Allergy to device materials","ALL","18 Years",{"count":20,"type":21},200,"ESTIMATED","24 Months","OBSERVATIONAL","Objective To pragmatically collect and analyze patient-level clinical, procedural, and outcome data from participating centers in Italy and Poland on the use of the PERCUTEK Tycheseal™ stent-graft system for the endovascular repair of abdominal aortic aneurysms. The study aims to generate high-quality, real-world evidence on the technical success, safety, and mid-term outcomes of the device.\n\nStudy Design This is a pragmatic, observational, multicenter physician-initiated registry that will collect patient-level data for all eligible patients undergoing PERCUTEK Tycheseal™ device implantation. Each site will enter data into a standardized paper case report form (CRF), including demographic, anatomical, procedural, and follow-up variables. Sites will be expected to comply with data entry timelines and quality control checks. The total projected enrollment is 120-200 patients across all sites over an expected 18 month inclusion period.\n\nThe target enrollment is 120-200 patients across all participating sites.",[26],"Abdominal Aortic Aneurysm",[28,29,30,31,32],"Abdominal aortic aneurysm","Endovascular Aneurysm Repair","PERCUTEK Tycheseal™","vascular disease","stent graft","RECRUITING","2026-03-18",{"date":36,"type":37},"2026-03-20","ACTUAL",{"date":39,"type":37},"2026-03-01",{"date":41,"type":21},"2030-03-31",{"name":43,"class":44},"American Heart of Poland","OTHER",26,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100156656","revascularization-strategies-in-patients-with-non-st-segment-elevation-acute-coronary-syndrome-nste-acs-and-severe-coronary-artery-disease-100156656","NCT01311323","Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease","Multivessel and Left Main Coronary Artery Stenting in Comparison With Surgical Revascularization in Patients With Non ST Elevation Acute Coronary Syndrome. Prospective, Clinical Randomized Trial (The MILESTONE Trial)","MILESTONE","Inclusion Criteria:\n\nSubjects must meet ALL of the inclusion criteria to be considered for the trial. If ANY of the exclusion criteria are met, the subject is excluded from the trial and cannot be randomized.\n\n* Age over 18 years,\n* Written patient consent,\n* Acute Coronary Syndrome without ST-segment elevation of high, intermediate and low risk, including NSTEMI and unstable angina requiring urgent (within 72 hours) invasive strategy,\n* Qualification for invasive treatment,\n* Multivessel coronary disease, defined as angiographic narrowing \\>50%DS on investigator's visual assessment in at least two major coronary artery territories (RCA, LAD, LCX), including involvement of the proximal segment of the left anterior descending artery or three-vessel disease with a Syntax Score \\\u003C 33. Intermediate lesions (40-70%) will need to be assessed with either FFR, iFR, or VFFR). Patient may have left main coronary artery disease, defined as narrowing \\>50%DS (but this is not obligatory). For borderline changes, IVUS (MLA \\\u003C6 mm2 or iFR=\\\u003C0,90 or FFR=\\\u003C0,80, with an anatomic Syntax Score \\\u003C33 will be decisive,\n* Feasibility of complete revascularization on both the CABG and PCI sides,\n* Consent within the Heart Team for both CABG by the cardiothoracic surgeon and PCI by the interventional cardiologist.\n\nExclusion Criteria:\n\n* Age under 18 years,\n* ST-segment elevation myocardial infarction (STEMI) or new left bundle branch block (LBBB),\n* Stable coronary syndrome,\n* Single- or two-vessel coronary disease without involvement of the proximal LAD, defined as narrowing above 50%DS,\n* Qualification for conservative treatment,\n* Anticipated surgery other than CABG due to severe valvular defect or other structural defect, particularly moderate or severe mitral regurgitation,\n* Need for immediate coronary angioplasty treatment,\n* Syntax Score equal or above 33 (\\>=33),\n* Contraindications to short-term and long-term antiplatelet therapy,\n* Acute heart failure in class IV (cardiogenic shock),\n* Previous CABG procedure,\n* Previous PCI procedure within the last 6 months,\n* Ischemic or hemorrhagic stroke within 6 months prior to inclusion,\n* End-stage chronic kidney disease on dialysis,\n* Pregnancy or intention to become pregnant (women of child bearing age must have a recent negative pregnancy test prior to randomization),\n* Non cardiac co-morbidities with life expectancy less than 3 years,\n* Participation in other clinical trial that have not reached their primary endpoint.",{"count":55,"type":21},1000,"INTERVENTIONAL",[58],"NA","MILESTONE STUDY is dedicated to problems connected with patients with multivessel coronary artery disease and\u002For with left main narrowing who present symptoms of acute ischemia. For such kind of patients according to current ACC\u002FAHA guidelines CABG (surgical revascularization) is recommended as a treatment method. In comparison with CABG, recent studies have shown that PCI (percutaneous coronary intervention) is associated with a lower rate of periprocedural adverse events and similar long term event-free survival in patients with left main disease. Our latest non randomized registry and randomized LEMANS study, comparing LMCA (left main coronary artery) stenting with CABG confirmed above findings. LEMANS ACS (acute coronary syndrome) retrospective registry of patients with UPLMCA (unprotected LMCA) disease and non ST elevation ACS showed lower 30 day and trend toward lower one year mortality after PCI when compared with CABG. It should be stressed, that acute ischemia substantially increase the risk of CABG. In fact, there are limited data on the outcome of ULMCA stenting or CABG in patients with acute coronary syndromes (ACS).\n\nSimilarly, all randomized studies comparing PCI vs CABG in multivessel disease included mainly patients with stable angina, small cohort of patients with unstable angina and they excluded patients with non ST elevation Myocardial infarction.\n\nIn the SYNTAX study -largest PCI vs CABG trial, randomized patients were patients with low perioperative risk (logistic EUROSCORE \\\u003C5) and ACS patients routinely excluded. High perioperative risk patients were included only in PCI registry.",[61,62],"Multivessel Coronary Artery Disease","Acute Coronary Syndrome",[61,64,65,66,67,68,69,70],"Left Main Narrowing","Percutaneous Coronary Intervention","Coronary Artery Bypass Grafting","Drug-Eluting Stent","Fractional Flow Reserve","Instant wave-free ratio","virtual Fractional Flow Reserve","2026-02-20",{"date":73,"type":37},"2026-02-23",{"date":75,"type":37},"2025-08-25",{"date":77,"type":21},"2030-11",{"name":43,"class":44},7,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":56,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},"100498746","pacemaker-implantation-versus-cardioneuroablation-for-functional-atrioventricular-block-100498746","NCT05774262","Pacemaker Implantation Versus Cardioneuroablation for Functional Atrioventricular Block","TELE-monitoring for Standard Pacemaker Implantation or Delayed Pacemaker Implantation After Autonomic\u002FElectrophysiologic Evaluation and Cardioneuroablation for managEment of Functional atrioventriculaR Block - Randomized Controlled Study","TELE-SPACER","Inclusion Criteria:\n\n1. Written informed consent to participate in the study\n2. Age 18-75\n3. Indication (at least one) of the European Society of Cardiology (ESC) for elective pacemaker implantation due to isolated (without sinus node dysfunction and bundle branch block) paroxysmal, persistent or reflex atrioventricular block:\n\n   1. Symptomatic first degree AVB (above 300 msec). Class IIaC\n   2. Symptomatic Mobitz type I second degree AVB. Class IIaC\n   3. AVB 2:1, even asymptomatic, but not during sleep. Class IIaC\n   4. Mobitz II type advanced 2nd degree AVB or complete block (3rd degree AVB). Class IC\n   5. Advanced AVB during AF regardless of symptoms, but not during sleep. Class IC\n   6. Reflex syncope in patients over 40 years of age with documented pauses within the AVB mechanism, symptomatic (\\>3 sec) or asymptomatic \\>6 sec. Class IC\n   7. Reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism in the course of sick sinus syndrome (CSS). Class IC\n   8. Reflex syncope in patients over 40 years of age with documented pauses within AVB mechanism during tilt test. Class IC\n\nExclusion Criteria:\n\n1. Implanted pacemaker\u002FICD\u002FCRT\n2. Sinus node dysfunction with indication for pacemaker implantation\n3. Planned ablation of the atrioventricular junction\n4. Severe prolonged bradycardia in advanced AVB requiring intravenous drugs and temporary pacing\n5. Status post cardiac surgery\n6. Acute myocardial infarction and heart failure (not related to bradycardia)\n7. Status post percutaneous valvular intervention or ablation\n8. Acute infection or any other accompanying disease which is contraindication to percutaneous procedures and\u002For implantation of a pacemaker\n9. Pregnancy, nursing or planned pregnancy within 12 months\n10. Decompensated chronic diseases (endocrine disorders, electrolyte disorders, etc.)\n11. Advanced cardiomyopathies with indication for ICD implantation in primary or secondary prevention of sudden cardiac death (SCD)\n12. Advanced ventricular arrhythmias with indication for ICD implantation in primary or secondary prevention of SCD\n13. Persistent right or left bundle branch block\n14. Musculoskeletal diseases with separate indications for pacemaker implantation\n15. Contraindications to the procedures used in the study\n16. The presence of a mental illness or limitation of cognitive functions that prevent independent participation in the study, including the use of telemedicine services\n17. Any abnormality found that is considered by the Principal Investigator a contraindication to participate in the stidy due to data interpretation or safety issue","75 Years",{"count":90,"type":21},300,[58],"The TELE-SPACER study is a multicenter, noncommercial, physician-initiated, proof-of-concept, prospective, randomized, controlled, unblinded clinical trial and registry designed to compare two methods of treatment of patients with functional Atrio-Ventricular Block (AVB): the guidelines-recommended elective pacemaker (PM) therapy vs cardiovascular autonomic tests (CAT), electrophysiologic assessment (EPS) with referral to cardioneuroablation (CNA) and reevaluation of indications for PM therapy.\n\nThe main questions TELE-SPACER aims to answer are:\n\n* Can the investigators successfully treat functional AVB without implantable device (PM)?\n* Can the investigators prove the feasibility and safety and demonstrate non-inferiority of CNA procedure in patients with functional AVB, avoiding long-term permanent pacing, its limitations, complications and costs ?\n\nThe TELE-SPACER trial will validate the European Society of Cardiology (ESC) recommendations (level C of evidence: expert opinion) for elective PM implantation and will introduce CNA as effective treatment in the functional AVB patient population.\n\nFunctional AVB - defined as a persistent or paroxysmal AVB with a positive results of atropine test",[94],"Atrioventricular Block",[96,97,98,99,100],"AVB","Pacemaker implantation","Cardioneuroablation","Cardiovascular autonomic testing (CAT)","Telemedicine","2024-03-14",{"date":103,"type":37},"2024-03-18",{"date":105,"type":37},"2023-09-01",{"date":107,"type":21},"2026-12-31",{"name":43,"class":44},2,""]