[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567737":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":39,"locations":47,"responsibleParty":282,"collaborators":284,"id":290,"slug":291,"hasResults":292,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":292,"sex":298,"minAge":299,"maxAge":26,"enrollmentInfo":300,"targetDuration":26,"studyType":303,"phases":304,"briefSummary":306,"conditions":307,"keywords":309,"overallStatus":50,"whyStopped":26,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":321},{"fullName":5,"class":6},"Leipzig Heart Science gGmbH","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"conventional care","ACTIVE_COMPARATOR","Patients in the conventional care group will receive guideline directed therapy including reperfusion treatment. If no clinically relevant hemodynamic improvement occurs, catheter-interventional treatment may be used as stated in the current ESC-guidelines",[13],"Drug: Conventional care",{"label":15,"type":16,"description":17,"interventionNames":18},"Early Catheter-Interventional Treatment + conventional care","EXPERIMENTAL","Patients in this group will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration, if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these. Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation. The choice of the catheter types and sizes will be left to the treating interventionalists' discretion.",[19,13],"Procedure: Early Catheter-Interventional Treatment",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Early Catheter-Interventional Treatment","Patients will undergo a catheter-interventional treatment within 60 min. after randomization. Fibrinolytic treatment will be prepared parallel to interventional treatment preparations to avoid any delay in its administration if clinically necessary. Catheter-interventional treatment may include any certified devices for the treatment of PE including aspiration thrombectomy, local fibrinolytic therapy, local ultrasound treatment as assistance to local fibrinolysis or any combination of these.Transfemoral venous access routes will be used for any catheter-directed treatment using sheath-sizes as recommended in the IFUs by the respective manufacturers. Sheaths will be withdrawn immediately after catheter-based thrombectomy or after completion of catheter-directed local fibrinolysis, typically 5 to 10 hours after initiation.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Conventional care","reperfusion treatment",[15,9],[33,37],{"name":34,"affiliation":35,"role":36},"Karl Fengler, MD, Assoc. Prof.","Heart Center Leipzig at University of Leipzig, Department of Internal Medicine\u002FCardiology","STUDY_CHAIR",{"name":38,"affiliation":35,"role":36},"Holger Thiele, MD. Prof.",[40,44],{"name":34,"role":41,"phone":42,"phoneExt":26,"email":43},"CONTACT","+49 341 865-1426","karl.fengler@medizin.uni-leipzig.de",{"name":45,"role":41,"phone":26,"phoneExt":26,"email":46},"Holger Thiele, MD, Prof. Dr.","holger.thiele@medizin.uni-leipzig.de",[48,64,82,94,108,122,136,148,160,172,186,198,206,218,232,246,258,270],{"facility":49,"status":50,"city":51,"state":26,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Universitätsklinikum Freiburg","RECRUITING","Bad Krozingen","79189","Germany","DE",{"type":56,"coordinates":57},"Point",[58,59],7.7,47.91667,{"lat":59,"lon":58},[62],{"name":63,"role":41,"phone":26,"phoneExt":26,"email":26},"Elias Noory, MD",{"facility":65,"status":50,"city":66,"state":26,"zip":67,"country":53,"countryCode":54,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Oberlausitzklinikum Bautzen, Medizinische Klinik I","Bautzen","02625",{"type":56,"coordinates":69},[70,71],14.43494,51.18035,{"lat":71,"lon":70},[74,78],{"name":75,"role":41,"phone":76,"phoneExt":26,"email":77},"Dr. med. Servi R. Ada, Dr. med.","03591 36377288","ServiRemzi.Ada@Oberlausitz-Kliniken.de",{"name":79,"role":41,"phone":80,"phoneExt":26,"email":81},"Prof. Dr. Steffen Schön, Prof. Dr.","03591 36377143","Steffen.Schoen@Oberlausitz-Kliniken.de",{"facility":83,"status":50,"city":84,"state":26,"zip":85,"country":53,"countryCode":54,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Universitätsklinikum Bonn","Bonn","53127",{"type":56,"coordinates":87},[88,89],7.09549,50.73438,{"lat":89,"lon":88},[92],{"name":93,"role":41,"phone":26,"phoneExt":26,"email":26},"Georg Nickenig, MD",{"facility":95,"status":50,"city":96,"state":26,"zip":97,"country":53,"countryCode":54,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Universitätsklinik Düsseldorf, Klinik für Kardiologie, Pneumologie und Angiologie","Düsseldorf","40225",{"type":56,"coordinates":99},[100,101],6.77927,51.22319,{"lat":101,"lon":100},[104],{"name":105,"role":41,"phone":106,"phoneExt":26,"email":107},"Dr. med. Lucas Busch Busch, Dr. med.","+49 2118108753","HansLucas.Busch@med.uni-duesseldorf.de",{"facility":109,"status":50,"city":110,"state":26,"zip":111,"country":53,"countryCode":54,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"HELIOS Klinikum Erfurt","Erfurt","99089",{"type":56,"coordinates":113},[114,115],11.03536,50.97734,{"lat":115,"lon":114},[118],{"name":119,"role":41,"phone":120,"phoneExt":26,"email":121},"Prof. Dr. Alexander Lauten, Prof. Dr.","+49 361 781 2481","alexander.lauten@helios-gesundheit.de",{"facility":123,"status":50,"city":124,"state":26,"zip":125,"country":53,"countryCode":54,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Universitätsklinikum Frankfurt, Med. Klinik III - Kardiologie, Angiologie","Frankfurt am Main","60590",{"type":56,"coordinates":127},[128,129],8.68417,50.11552,{"lat":129,"lon":128},[132],{"name":133,"role":41,"phone":134,"phoneExt":26,"email":135},"PD Dr. med. Robert Stöhr, PD Dr. med.","+49 69630185884","robert.stoehr@unimedizin-ffm.de",{"facility":137,"status":50,"city":138,"state":26,"zip":139,"country":53,"countryCode":54,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Universitätsklinikum Halle","Halle","06120",{"type":56,"coordinates":141},[142,143],11.97947,51.48158,{"lat":143,"lon":142},[146],{"name":147,"role":41,"phone":26,"phoneExt":26,"email":26},"Alexander Vogt, MD",{"facility":149,"status":50,"city":150,"state":26,"zip":151,"country":53,"countryCode":54,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Asklepios Klinik St. Georg","Hamburg","20099",{"type":56,"coordinates":153},[154,155],9.99302,53.55073,{"lat":155,"lon":154},[158],{"name":159,"role":41,"phone":26,"phoneExt":26,"email":26},"Eike Tigges, MD",{"facility":161,"status":50,"city":162,"state":26,"zip":163,"country":53,"countryCode":54,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"SLK-Kliniken Heilbronn","Heilbronn","74078",{"type":56,"coordinates":165},[166,167],9.22054,49.13995,{"lat":167,"lon":166},[170],{"name":171,"role":41,"phone":26,"phoneExt":26,"email":26},"Markus Hennersdorf, MD",{"facility":173,"status":50,"city":174,"state":26,"zip":175,"country":53,"countryCode":54,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Westpfalz-Klinikum GmbH, Klinik für Innere Medizin 2","Kaiserslautern","67655",{"type":56,"coordinates":177},[178,179],7.77161,49.443,{"lat":179,"lon":178},[182],{"name":183,"role":41,"phone":184,"phoneExt":26,"email":185},"Prof. Dr. med. Burghard Schumacher, Prof. Dr. med.","+49 631 2031079","bschumacher@westpfalz-klinikum.de",{"facility":187,"status":50,"city":188,"state":26,"zip":189,"country":53,"countryCode":54,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"Universitätsklinikum Leipzig","Leipzig","04103",{"type":56,"coordinates":191},[192,193],12.37129,51.33962,{"lat":193,"lon":192},[196],{"name":197,"role":41,"phone":26,"phoneExt":26,"email":26},"Karsten Lenk, MD",{"facility":35,"status":50,"city":188,"state":26,"zip":199,"country":53,"countryCode":54,"cosmosGeoPoint":200,"geoPoint":202,"contacts":203},"04289",{"type":56,"coordinates":201},[192,193],{"lat":193,"lon":192},[204],{"name":205,"role":41,"phone":26,"phoneExt":26,"email":26},"Karl Fengler, MD",{"facility":207,"status":50,"city":208,"state":26,"zip":209,"country":53,"countryCode":54,"cosmosGeoPoint":210,"geoPoint":214,"contacts":215},"Universitätsklinikum Mannheim","Mannheim","68167",{"type":56,"coordinates":211},[212,213],8.46694,49.4891,{"lat":213,"lon":212},[216],{"name":217,"role":41,"phone":26,"phoneExt":26,"email":26},"Ibrahim Akin, MD",{"facility":219,"status":50,"city":220,"state":26,"zip":221,"country":53,"countryCode":54,"cosmosGeoPoint":222,"geoPoint":226,"contacts":227},"Klinik für Innere Medizin 8 Schwerpunkt Kardiologie Universitätsklinik der Paracelsus Medizinischen Privatuniversität Klinikum Nürnberg I Campus Süd","Nuremberg","90471",{"type":56,"coordinates":223},[224,225],11.07752,49.45421,{"lat":225,"lon":224},[228],{"name":229,"role":41,"phone":230,"phoneExt":26,"email":231},"Dr. med. Simon Roth, Dr. med.","+49 911398118722","Simon.Roth@klinikum-nuernberg.de",{"facility":233,"status":50,"city":234,"state":26,"zip":235,"country":53,"countryCode":54,"cosmosGeoPoint":236,"geoPoint":240,"contacts":241},"Bundeswehrkrankenhaus Ulm, Abteilung I - Innere Medizin, Schwerpunkt Kardiologie","Ulm","89081",{"type":56,"coordinates":237},[238,239],9.99155,48.39841,{"lat":239,"lon":238},[242],{"name":243,"role":41,"phone":244,"phoneExt":26,"email":245},"Dr. med. Jakob Lindner, Dr. med.","+49 731 171031013","jakob1Lindner@bundeswehr.org",{"facility":247,"status":50,"city":248,"state":26,"zip":249,"country":53,"countryCode":54,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"Schwarzwald-Baar-Klinikum","Villingen-Schwenningen","78052",{"type":56,"coordinates":251},[252,253],8.49358,48.06226,{"lat":253,"lon":252},[256],{"name":257,"role":41,"phone":26,"phoneExt":26,"email":26},"Sebastian Ewen, MD",{"facility":259,"status":50,"city":260,"state":26,"zip":261,"country":53,"countryCode":54,"cosmosGeoPoint":262,"geoPoint":266,"contacts":267},"Rems-Murr-Kliniken","Winnenden","71364",{"type":56,"coordinates":263},[264,265],9.39819,48.87563,{"lat":265,"lon":264},[268],{"name":269,"role":41,"phone":26,"phoneExt":26,"email":26},"Dirk Mühlberger, MD",{"facility":271,"status":50,"city":272,"state":26,"zip":273,"country":53,"countryCode":54,"cosmosGeoPoint":274,"geoPoint":278,"contacts":279},"Helios Kliniken Wuppertal","Wuppertal","42117",{"type":56,"coordinates":275},[276,277],7.14816,51.25627,{"lat":277,"lon":276},[280],{"name":281,"role":41,"phone":26,"phoneExt":26,"email":26},"Alexander Wolf, MD",{"type":283,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[285,288],{"name":286,"class":287},"Heart Center Leipzig at University of Leipzig","UNKNOWN",{"name":289,"class":6},"Helios Health Institute GmbH","100567737","early-catheter-directed-treatment-of-high-risk-pulmonary-embolism-100567737",false,"NCT06672081","Early Catheter-directed Treatment of High Risk Pulmonary Embolism","A Randomized Trial for Early Catheter-directed Treatment of High Risk Pulmonary Embolism","CATCH-PE II","Inclusion Criteria:\n\n1. Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:\n\n   a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP \\\u003C90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol\u002FL) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan\n2. Age ≥18 years\n\nExclusion Criteria:\n\n1. Contraindications for catheter-based treatment\n2. Contraindications to systemic fibrinolytic treatment or anticoagulation\\*\n\n   1. Active, potentially life-threatening bleeding\n   2. Surgery within 24h before screening\n   3. Cranial or spinal surgery within 14d before screening\n   4. Stroke within 14d before screening\n   5. Intracranial tumor\n   6. Any condition not listed here but estimated as clinically relevant as judged by the treating investigator\n3. Pregnancy\n\n   * Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.","ALL","18 Years",{"count":301,"type":302},210,"ESTIMATED","INTERVENTIONAL",[305],"NA","Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism",[308],"Pulmonary Embolism Acute Massive",[310,311],"pulmonary embolism","early catheter-directed treatment","2026-03-03",{"date":314,"type":315},"2026-03-04","ACTUAL",{"date":317,"type":315},"2024-12-27",{"date":319,"type":302},"2027-06-30",{"name":5,"class":6},18]