[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05868161":3,"trial-entities:NCT05868161":214,"trial-summary:NCT05868161":219},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":16,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":35,"secondary_outcomes":44,"sex":111,"minimum_age":112,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":113,"std_ages":120,"locations":123,"central_contacts":198,"overall_officials":204,"references":212,"see_also_links":213},"NCT05868161","SUR22-001","Pounce™ Thrombectomy System Retrospective Registry","RECRUITING","2026-07-31","2025-09","2025-09-11","2023-04-18","SurModics, Inc.","INDUSTRY",false,"The PROWL registry is an open-label retrospective, multi-center, US study of the Surmodics™ Pounce™ Thrombectomy System for the non-surgical removal of emboli and thrombi in the peripheral arterial vasculature.",null,[18,19],"Peripheral Arterial Disease","Acute Limb Ischemia",[],"OBSERVATIONAL",[],{"count":24,"type":25},500,"ESTIMATED",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":33},"DEVICE","Pounce Thrombectomy System","Non-surgical removal of thrombi and emboli from the peripheral arterial vasculature with the Pounce Thrombectomy System.",[32],"Retrospective",[34],"Mechanical thrombectomy",[36,40],{"measure":37,"description":38,"timeFrame":39},"Procedural Success","Restoration of pulsatile flow in the target lesion(s) with or without adjunctive treatment as determined by the core lab and physician","Peri-procedural (by the end of the index procedure)",{"measure":41,"description":42,"timeFrame":43},"Incidence of device related Major Adverse Events (MAEs)","Death, Unplanned major amputation (above ankle), Clinically Driven target lesion revascularization (TLR)","Procedure to 30 days",[45,48,51,54,58,61,64,67,70,74,76,78,80,82,84,88,91,95,99,102,104,106,108],{"measure":46,"description":47,"timeFrame":39},"Technical success","Restoration of blood flow to the target lesion(s) with \\\u003C50% residual thrombus without the need to initiate CDT or to proceed to open surgery or other endovascular thrombectomy device as determined by the core lab",{"measure":49,"description":50,"timeFrame":39},"Completeness of thromboemboli removal (by angiography)","Completeness of thromboemboli removal (by angiography) not including underlying atheroma as determined by the core lab and physician",{"measure":52,"description":53,"timeFrame":39},"Thrombo-aspiration in Peripheral Interventions (TIPI) flow rate","TIPI flow rate at the end of thrombectomy procedure and after any adjunctive procedures as determined by the core lab and physician.",{"measure":55,"description":56,"timeFrame":57},"Modified Society for Vascular Surgery (SVS) runoff","Pre-procedure vs. post-procedure runoff using a modified SVS runoff score as determined by the core lab and physician (if applicable).","Pre-procedure, Peri-procedural (by the end of the index procedure)",{"measure":59,"description":60,"timeFrame":39},"Underlying atheroma stenosis","Length of underlying atheroma stenosis necessitating treatment compared to original lesion length as determined by the core lab and physician",{"measure":62,"description":63,"timeFrame":39},"Describe index procedural characteristics","Number of passes of Pounce Thrombectomy System\n\n* Total number of passes\n* Number of passes in each vessel",{"measure":65,"description":66,"timeFrame":39},"Adjunctive procedures","Percentage of subjects in whom adjunctive procedures were performed\n\n▪ Treatment for: underlying atheroma, residual thrombus, residual embolus, other",{"measure":68,"description":69,"timeFrame":39},"Index procedure durations","Total procedure duration (minutes) Duration of Pounce Thrombectomy System use (minutes)",{"measure":71,"description":72,"timeFrame":73},"Characterize subject index procedure hospitalization course at discharge","Length of stay","Index procedure hospital admission to discharge, approximately 1 to 2 days",{"measure":71,"description":75,"timeFrame":73},"Time from end of procedure to discharge",{"measure":71,"description":77,"timeFrame":73},"Incidence of same day discharge",{"measure":71,"description":79,"timeFrame":73},"Incidence of next day discharge",{"measure":71,"description":81,"timeFrame":73},"Incidence of ICU admission",{"measure":71,"description":83,"timeFrame":73},"Duration of ICU admission",{"measure":85,"description":86,"timeFrame":87},"Primary vessel patency","Determined by the investigator using DUS or ABI","30 days",{"measure":89,"description":90,"timeFrame":43},"Rutherford class (if applicable)","Improvement by at least one class at 30 days as compared to procedure",{"measure":92,"description":93,"timeFrame":94},"Rutherford classification (if applicable)","Characterize Rutherford classification","Baseline, at hospital discharge (approximately 1-2 days), 30 days",{"measure":96,"description":97,"timeFrame":98},"Ankle Brachial Index (ABI)","Change in ABI at 30 days compared to baseline.","Baseline to 30 days",{"measure":100,"description":101,"timeFrame":87},"Incidence of device related arterial AEs","Major bleeding (requiring transfusion) Arterial perforation Flow-limiting dissection (at the end of the procedure, prior to and following stenting, if performed) Distal embolization requiring surgical procedure or obstructing one of the major downstream vessels \\>70% (at the end of the procedure)",{"measure":103,"timeFrame":87},"Incidence of all-cause: Death Unplanned major amputation (above ankle) Clinically driven TLR Clinically driven TVR",{"measure":105,"timeFrame":87},"Incidence of: Procedure-related SAEs Device-related (S)AEs",{"measure":107,"timeFrame":87},"Incidence of: Compartment syndrome requiring fasciotomy Major bleeding (requiring transfusion) unrelated to device",{"measure":109,"description":110,"timeFrame":87},"Incidence of index procedure access site complications","Infection (requiring IV antibiotics or surgical treatment) Pseudoaneurysm (requiring surgical or endovascular treatment) Seroma (requiring surgical treatment) Other access site related AEs\n\n* Numbness\n* Other","ALL","18 Years",{"inclusion":114,"exclusion":117,"raw_text":119},[115,116],"Subject underwent an endovascular intervention where the Pounce Thrombectomy System was attempted","Subject is willing and able to provide informed consent prior to the collection of study data or a consent waiver is in place",[118],"Subject is under the age of 18 years","Inclusion Criteria:\n\n* Subject underwent an endovascular intervention where the Pounce Thrombectomy System was attempted\n* Subject is willing and able to provide informed consent prior to the collection of study data or a consent waiver is in place\n\nExclusion Criteria:\n\n* Subject is under the age of 18 years",[121,122],"ADULT","OLDER_ADULT",[124,133,142,150,158,166,174,182,190],{"facility":125,"status":7,"city":126,"state":127,"zip":128,"country":129,"geoPoint":130},"OSF St. Francis Medical Center","Peoria","Illinois","61637","United States",{"lat":131,"lon":132},40.69365,-89.58899,{"facility":134,"status":135,"city":136,"state":137,"zip":138,"country":129,"geoPoint":139},"Community Hospital","COMPLETED","Munster","Indiana","46321",{"lat":140,"lon":141},41.56448,-87.51254,{"facility":143,"status":7,"city":144,"state":145,"zip":146,"country":129,"geoPoint":147},"Baton Rouge General Medical Center","Baton Rouge","Louisiana","70809",{"lat":148,"lon":149},30.44332,-91.18747,{"facility":151,"status":135,"city":152,"state":153,"zip":154,"country":129,"geoPoint":155},"Allina Health","Minneapolis","Minnesota","55407",{"lat":156,"lon":157},44.97997,-93.26384,{"facility":159,"status":7,"city":160,"state":161,"zip":162,"country":129,"geoPoint":163},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":164,"lon":165},41.4995,-81.69541,{"facility":167,"status":7,"city":168,"state":169,"zip":170,"country":129,"geoPoint":171},"Prisma Health Upstate","Greenville","South Carolina","29601",{"lat":172,"lon":173},34.85262,-82.39401,{"facility":175,"status":7,"city":176,"state":177,"zip":178,"country":129,"geoPoint":179},"North Central Heart","Sioux Falls","South Dakota","57108",{"lat":180,"lon":181},43.54369,-96.72796,{"facility":183,"status":7,"city":184,"state":185,"zip":186,"country":129,"geoPoint":187},"Vanderbilt University Medical Center","Nashville","Tennessee","37212",{"lat":188,"lon":189},36.16589,-86.78444,{"facility":191,"status":7,"city":192,"state":193,"zip":194,"country":129,"geoPoint":195},"Ascension Seton","Austin","Texas","78723",{"lat":196,"lon":197},30.26715,-97.74306,[199],{"name":200,"role":201,"phone":202,"email":203},"Clinical Program Manager","CONTACT","1-866-787-6639","PROWLRegistry@surmodics.com",[205,209],{"name":206,"affiliation":207,"role":208},"Sean Lyden, MD","The Cleveland Clinic","PRINCIPAL_INVESTIGATOR",{"name":210,"affiliation":211,"role":208},"Joseph Campbell, MD","OhioHealth",[],[],{"nct_id":4,"conditions":215,"biomarkers":218},[216,217],"Limb ischemia","Peripheral Artery Disease",[],{"nct_id":4,"found":220,"summary":221,"prompt_version":231},true,{"design":222,"status":223,"heading":224,"summary":225,"follow_up":226,"word_count":227,"commitments":228,"compensation":229,"drugs_mentioned":230},"This is an observational study, meaning researchers are looking at existing patient data. It is an open-label, multi-center study in the US, planning to include information from about 500 participants.","completed","Pounce™ Thrombectomy System for Peripheral Arterial Disease and Acute Limb Ischemia","This study is looking back at information from patients who have already received treatment with the Pounce™ Thrombectomy System. This system is a device used to non-surgically remove blood clots (thrombi) and blockages (emboli) from arteries in the legs and arms (peripheral arterial vasculature). The study aims to understand how successful the procedure is and if there are any device-related serious problems (Major Adverse Events) within 30 days. You could be included in this study if you are 18 years or older, have had this procedure, and are able to provide consent for your data to be used. This study is currently gathering information and is not actively recruiting new patients for treatment.","Researchers will look at information about any device-related serious problems for up to 30 days after the procedure.",113,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]