[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07350499":3,"trial-entities:NCT07350499":235,"trial-summary:NCT07350499":240},{"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":22,"study_type":29,"primary_purpose":17,"phases":30,"enrollment_info":31,"interventions":34,"primary_outcomes":48,"secondary_outcomes":60,"sex":146,"minimum_age":147,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":148,"std_ages":152,"locations":155,"central_contacts":219,"overall_officials":225,"references":233,"see_also_links":234},"NCT07350499","ICI-2025-002","Aspiration Thrombectomy Using the Symphony or Prodigy System","Long-Term CLinical Evaluation of Aspiration ThRombectomy Using the Symphony or ProdIgy Thrombectomy System - CLEAR-IT","RECRUITING","2030-09","2026-06","2026-07-27","2026-02-13","Imperative Care, Inc.","INDUSTRY",false,"The study is designed to evaluate the short-term and long-term clinical performance and safety of the Symphony and Prodigy thrombectomy systems used in endovascular procedures across the peripheral or pulmonary vasculature.",null,[19,20,21],"Arterial Thromboembolism","Venous Thromboembolism","Pulmonary Embolism",[21,23,24,25,26,27,28],"Thrombus","Thromboembolism","Aspiration","Aspiration thrombectomy","Anticoagulation","Peripheral vasculature","OBSERVATIONAL",[],{"count":32,"type":33},750,"ESTIMATED",[35,41,45],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Prodigy Thrombectomy System","Removal of thrombus\u002Femboli from blood vessels in the peripheral vasculature",[40],"Peripheral Arterial",{"type":36,"name":42,"description":38,"armGroupLabels":43},"Symphony Thrombectomy System",[44],"Peripheral Venous",{"type":36,"name":42,"description":46,"armGroupLabels":47},"Removal of thrombus\u002Femboli from the pulmonary vasculature",[21],[49,53,56],{"measure":50,"description":51,"timeFrame":52},"Peripheral Arterial Cohort","Freedom from major (above-ankle) unanticipated amputation of the index limb","30 days",{"measure":54,"description":55,"timeFrame":52},"Peripheral Venous Cohort","Treated limb improvement at 30 days, defined as no unplanned intervention for breakthrough re-thrombosis and improvement in Villalta score relative to baseline.",{"measure":57,"description":58,"timeFrame":59},"Pulmonary Embolism (PE) Cohort","Normal right ventricular function at 30 days follow-up, defined as tricuspid annular plane systolic excursion (TAPSE) \\>1.7cm , measured on transthoracic echocardiography (TTE) and independently adjudicated.","30 Days",[61,64,66,68,69,70,72,73,74,76,77,78,80,81,82,84,85,87,88,89,92,95,98,101,103,105,106,108,110,111,113,114,115,116,119,121,123,125,127,129,130,132,134,135,137,138,139,141,142,143,144,145],{"measure":50,"description":62,"timeFrame":63},"Freedom from major (above-ankle) amputation of the index limb","90 Days",{"measure":50,"description":62,"timeFrame":65},"180 Days",{"measure":50,"description":67,"timeFrame":59},"Major adverse cardiovascular events (MACE) rate",{"measure":50,"description":67,"timeFrame":63},{"measure":50,"description":67,"timeFrame":65},{"measure":50,"description":71,"timeFrame":59},"Target vessel patency assessed using change in ankle-brachial index",{"measure":50,"description":71,"timeFrame":63},{"measure":50,"description":71,"timeFrame":65},{"measure":50,"description":75,"timeFrame":59},"Target vessel patency assessed using change in Rutherford claudication grade",{"measure":50,"description":75,"timeFrame":63},{"measure":50,"description":75,"timeFrame":65},{"measure":50,"description":79,"timeFrame":59},"Rate of re-intervention for index limb due to re-thrombosis in patients who are compliant with prescribed medical management",{"measure":50,"description":79,"timeFrame":63},{"measure":50,"description":79,"timeFrame":65},{"measure":50,"description":83,"timeFrame":63},"Quality of life assessment using Vascular Quality of Life Questionnaire-6 (VASCUQOL-6)",{"measure":50,"description":83,"timeFrame":65},{"measure":50,"description":86,"timeFrame":59},"All-cause mortality",{"measure":50,"description":86,"timeFrame":63},{"measure":50,"description":86,"timeFrame":65},{"measure":54,"description":90,"timeFrame":91},"Technical success defined as complete or near complete (\\>75%) reduction in Marder score from baseline to immediately after the use of the device and prior to any use of adjunctive device, as independently adjudicated","Intraprocedural",{"measure":54,"description":93,"timeFrame":94},"Rate of Major Adverse Events (MAEs) as adjudicated by an independent medical monitor and defined as the occurrence of any of the following:\n\n* Major bleeding\n* Device-related mortality\n* Device-related Serious Adverse Events (SAE)","48 hours",{"measure":54,"description":96,"timeFrame":97},"Treated limb improvement at 90 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline","90",{"measure":54,"description":99,"timeFrame":100},"Treated limb improvement at 180 days, defined as no unplanned intervention for re-thrombosis in patients who are compliant with prescribed medical management and improvement in Villalta score relative to baseline","180",{"measure":54,"description":102,"timeFrame":59},"Proportion of patients demonstrating decrease in Villalta score (A decrease in Villalta score reflects an improvement per the following scale: 0-4 - no disease; 5-9: mild disease; 10-14: moderate disease; 15 or \\> : severe disease)",{"measure":54,"description":104,"timeFrame":63},"Proportion of patients demonstrating decrease in Villalta score",{"measure":54,"description":104,"timeFrame":65},{"measure":54,"description":107,"timeFrame":59},"Unplanned intervention for imaging-confirmed re-thrombosis of the treated venous segment in patients who are compliant with prescribed medical management post index procedure.",{"measure":54,"description":107,"timeFrame":109},"60 Days",{"measure":54,"description":107,"timeFrame":65},{"measure":54,"description":112,"timeFrame":65},"Quality of life and symptom severity assessment using the Venous Insufficiency Epidemiological and Economic Study (VEINES -QOL); higher scores indicate better quality of life\u002Ffewer symptoms",{"measure":54,"description":86,"timeFrame":59},{"measure":54,"description":86,"timeFrame":63},{"measure":54,"description":86,"timeFrame":65},{"measure":117,"description":118,"timeFrame":91},"Pulmonary Embolism Cohort","Change in pulmonary artery pressure",{"measure":117,"description":120,"timeFrame":94},"Normal tricuspid annular plane systolic excursion (TAPSE) - independently adjudicated",{"measure":117,"description":122,"timeFrame":94},"Right ventricle fractional area change (FAC) on TTE pre-procedure, 48 hours - independently adjudicated",{"measure":117,"description":124,"timeFrame":59},"Right ventricle fractional area change (FAC) on TTE pre-procedure, 30 days - independently adjudicated",{"measure":117,"description":126,"timeFrame":94},"Tricuspid annular peak systolic velocity (S') pre-procedure, 48 hours - independently adjudicated",{"measure":117,"description":128,"timeFrame":59},"Tricuspid annular peak systolic velocity (S') pre-procedure, 30 days - independently adjudicated",{"measure":117,"description":93,"timeFrame":94},{"measure":117,"description":131,"timeFrame":52},"Right ventricle to left ventricle (RV\u002FLV) ratio reduction from baseline",{"measure":117,"description":133,"timeFrame":63},"Proportion of patients with improved or unchanged New York Hearth Association (NYHA) functional class",{"measure":117,"description":133,"timeFrame":65},{"measure":117,"description":136,"timeFrame":59},"Pulmonary Embolism recurrence",{"measure":117,"description":136,"timeFrame":63},{"measure":117,"description":136,"timeFrame":65},{"measure":117,"description":140,"timeFrame":59},"Quality of life assessed by the Pulmonary Embolism Quality of Life (PEmb-QoL) questionnaire",{"measure":117,"description":140,"timeFrame":63},{"measure":117,"description":140,"timeFrame":65},{"measure":117,"description":86,"timeFrame":59},{"measure":117,"description":86,"timeFrame":63},{"measure":117,"description":86,"timeFrame":65},"ALL","18 Years",{"inclusion":149,"exclusion":150,"raw_text":151},[],[],"Inclusion Criteria:\n\n1. Subject is ≥ 18 years of age\n2. Subject is willing and able to comply with the follow-up schedule specified in this protocol\n3. Subject is willing and able to provide written informed consent prior to any study-related data collection\n4. Subject has a planned procedure, involving the use of Imperative Care vascular devices within their intended use\n\nExclusion Criteria:\n\n1. Subjects with any contraindications per the applicable Instructions for Use\n2. Subject with life expectancy of less than 1 year\n3. In the opinion of the Investigator, the patient is not a suitable candidate for intervention with Imperative Care devices\n4. Subject who may be unable to complete study follow-up\n5. Peripheral Venous Cohort ONLY: Presence of thrombus extending more than 2 cm into the IVC on imaging",[153,154],"ADULT","OLDER_ADULT",[156,165,173,181,189,197,203,211],{"facility":157,"status":8,"city":158,"state":159,"zip":160,"country":161,"geoPoint":162},"Huntsville Hospital","Huntsville","Alabama","35801","United States",{"lat":163,"lon":164},34.7304,-86.58594,{"facility":166,"status":8,"city":167,"state":168,"zip":169,"country":161,"geoPoint":170},"BayCare Health - St. Joseph Hospital","Tampa","Florida","33607",{"lat":171,"lon":172},27.94752,-82.45843,{"facility":174,"status":8,"city":175,"state":176,"zip":177,"country":161,"geoPoint":178},"Midwest Cardiovascular Institute","Naperville","Illinois","60540",{"lat":179,"lon":180},41.78586,-88.14729,{"facility":182,"status":8,"city":183,"state":184,"zip":185,"country":161,"geoPoint":186},"Profound Research","Munster","Indiana","46321",{"lat":187,"lon":188},41.56448,-87.51254,{"facility":190,"status":8,"city":191,"state":192,"zip":193,"country":161,"geoPoint":194},"University At Buffalo","Buffalo","New York","14203",{"lat":195,"lon":196},42.88645,-78.87837,{"facility":198,"status":8,"city":192,"state":192,"zip":199,"country":161,"geoPoint":200},"Mount Sinai Hospital","10029",{"lat":201,"lon":202},40.71427,-74.00597,{"facility":204,"status":8,"city":205,"state":206,"zip":207,"country":161,"geoPoint":208},"Mercy Health","Cincinnati","Ohio","45242",{"lat":209,"lon":210},39.12711,-84.51439,{"facility":212,"status":8,"city":213,"state":214,"zip":215,"country":161,"geoPoint":216},"Sentara Norfolk General Hospital","Norfolk","Virginia","23502",{"lat":217,"lon":218},36.84681,-76.28522,[220],{"name":221,"role":222,"phone":223,"email":224},"Sylvie Akiel-Fu, MPH","CONTACT","917-375-4735","safu@imperativecare.com",[226,230],{"name":227,"affiliation":228,"role":229},"Steven Abramowitz, MD","Medstar Health Research Institute","PRINCIPAL_INVESTIGATOR",{"name":231,"affiliation":232,"role":229},"Maya Serhal, MD","Massachusetts General Hospital",[],[],{"nct_id":4,"conditions":236,"biomarkers":239},[237,238,21,24,20],"Arterial Thromboembolism, CTCAE","Blood Clot",[],{"nct_id":4,"found":241,"summary":242,"prompt_version":252},true,{"design":243,"status":244,"heading":245,"summary":246,"follow_up":247,"word_count":248,"commitments":249,"compensation":250,"drugs_mentioned":251},"This is an observational study involving 750 participants. It is designed to evaluate the performance and safety of medical devices.","completed","Observational Study of Symphony and Prodigy Thrombectomy Systems","This study is looking at how well the Symphony and Prodigy Thrombectomy Systems work and how safe they are. These systems are medical devices used to remove blood clots (thrombi\u002Femboli) from blood vessels in your arms, legs, or lungs. The study aims to understand their performance in people with arterial thromboembolism, venous thromboembolism, or pulmonary embolism. Researchers will follow 750 participants to see the short-term and long-term results. You might be able to join if you are 18 or older, willing to follow the study schedule, and are having a procedure that uses one of these devices. The study is currently unclear about its recruitment status.","Participants will be followed for 30 days to measure the primary outcomes related to their condition.",106,"You would need to be willing and able to comply with the follow-up schedule specified in the protocol. You would also need to provide written informed consent before any study-related data is collected.","Not stated in the trial record.",[37],"v2"]