[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100527790":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":29,"responsibleParty":91,"collaborators":20,"id":93,"slug":94,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":20,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":20,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":20,"overallStatus":32,"whyStopped":20,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Akura Medical","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with Acute Pulmonary Embolism","EXPERIMENTAL","Patients undergoing mechanical thrombectomy for acute pulmonary embolism.",[13],"Device: ATC System",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","ATC System","The ATC System is designed to mechanically remove emboli and restore blood flow through the pulmonary arteries in patients experiencing acute PE",[9],null,[22,27],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Rukhsana Khanum","CONTACT","+1 408-560-2500","clinicalaffairs@akuramed.com",{"name":28,"role":24,"phone":25,"phoneExt":20,"email":26},"Uday Illindala",[30,50,62,81],{"facility":31,"status":32,"city":33,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Instituto do Coracao","RECRUITING","São Paulo","05403-000","Brazil","BR",{"type":38,"coordinates":39},"Point",[40,41],-46.63611,-23.5475,{"lat":41,"lon":40},[44,47],{"name":45,"role":24,"phone":20,"phoneExt":20,"email":46},"Katiane Oliveira","katiane.oliveira@incor.usp.br",{"name":48,"role":49,"phone":20,"phoneExt":20,"email":20},"Rogerio Rogerio, Souza","PRINCIPAL_INVESTIGATOR",{"facility":51,"status":32,"city":33,"state":20,"zip":52,"country":35,"countryCode":36,"cosmosGeoPoint":53,"geoPoint":55,"contacts":56},"Instituto Dante Pazzanese de Cardiologia","04012-000",{"type":38,"coordinates":54},[40,41],{"lat":41,"lon":40},[57,60],{"name":58,"role":24,"phone":20,"phoneExt":20,"email":59},"Patricia Paiva","patricia.paiva@dantepazzanese.org.br",{"name":61,"role":49,"phone":20,"phoneExt":20,"email":20},"Fabio Rossi",{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Corazones Del Cibao","NOT_YET_RECRUITING","Santiago de los Caballeros","Santiago Province","51000","Dominican Republic","DO",{"type":38,"coordinates":71},[72,73],-70.69085,19.45036,{"lat":73,"lon":72},[76,78],{"name":77,"role":24,"phone":20,"phoneExt":20,"email":20},"Franklyn Colon",{"name":79,"role":24,"phone":20,"phoneExt":20,"email":80},"Rosa Hawa Fernandez","rosafdezhawa@gmail.com",{"facility":82,"status":32,"city":65,"state":66,"zip":20,"country":68,"countryCode":69,"cosmosGeoPoint":83,"geoPoint":85,"contacts":86},"Centro de Intervenciones Cardiovasculares",{"type":38,"coordinates":84},[72,73],{"lat":73,"lon":72},[87,89],{"name":88,"role":24,"phone":20,"phoneExt":20,"email":20},"Andres Marin, Dr.",{"name":90,"role":24,"phone":20,"phoneExt":20,"email":80},"Rosa Fernandez Hawa",{"type":92,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100527790","safety-and-effectiveness-of-the-atc-system-in-the-treatment-of-acute-pe-100527790",false,"NCT06152341","Safety and Effectiveness of the ATC System in the Treatment of Acute PE","Safety and Effectiveness of the ATC System in the Treatment of Acute Pulmonary Embolism","Inclusion Criteria:\n\n1. Patient is ≥ 18 and ≤ 90 years old\n2. Clinical signs and symptoms consistent with acute PE for \\\u003C 14 days\n3. CTA evidence of proximal PE\n4. RV\u002FLV ratio \\> 0.9\n5. Systolic BP ≥90 mmHg without the need for vasopressors\n6. Stable heart rate (HR) \\\u003C 130 BPM prior to procedure\n7. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment\n8. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures\n\nExclusion Criteria:\n\n1. Prior PE \\\u003C 180 days from index procedure\n2. Thrombolytic use \\\u003C 30 days prior to baseline CTA\n3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \\>70 mmHg by right heart catheterization\n4. FiO2 requirement \\>40% or \\>6 LPM to keep oxygen saturation \\>90%\n5. Hematocrit \\\u003C28%\n6. Platelets count \\\u003C100,000\u002FµL\n7. Serum creatinine \\>1.8 mg\u002FdL\n8. International normalized ratio (INR) \\>3\n9. Major trauma injury severity score (ISS) \\>15 prior to screening assessment\n10. Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment\n11. Cardiovascular or pulmonary surgery within 7 days of index procedure\n12. Actively progressing cancer treated by chemotherapeutics\n13. Known bleeding diathesis or coagulation disorder\n14. Left bundle branch block\n15. History of severe or chronic pulmonary arterial hypertension\n16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%\n17. History of decompensated heart failure\n18. History of underlying lung disease that is oxygen dependent\n19. History of chest irradiation\n20. History of heparin-induced thrombocytopenia (HIT)\n21. Contraindication to systemic or therapeutic doses of anticoagulants\n22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated\n23. Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention\n24. Life expectancy \\\u003C90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections\n25. Female who is pregnant or nursing\n26. Current participation in another investigational drug or device treatment study.","ALL","18 Years","90 Years",{"count":104,"type":105},30,"ESTIMATED","INTERVENTIONAL",[108],"NA","This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE).",[111],"Pulmonary Embolism Acute","2025-07-24",{"date":114,"type":115},"2025-07-28","ACTUAL",{"date":117,"type":115},"2024-05-15",{"date":119,"type":105},"2025-09-15",{"name":5,"class":6},4]