[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646889":3},{"organization":4,"outcomesModule":7,"designInfo":77,"detailedDescription":83,"studyPopulation":76,"armGroups":84,"interventions":91,"overallOfficials":76,"centralContacts":97,"locations":107,"responsibleParty":140,"collaborators":142,"id":146,"slug":147,"hasResults":148,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":76,"eligibilityCriteria":151,"healthyVolunteers":148,"sex":152,"minAge":153,"maxAge":154,"enrollmentInfo":155,"targetDuration":76,"studyType":158,"phases":159,"briefSummary":160,"conditions":161,"keywords":163,"overallStatus":128,"whyStopped":76,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},{"fullName":5,"class":6},"Vicora, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":76},[9,13],{"measure":10,"description":11,"timeFrame":12},"Safety Endpoint: Major Adverse Events","Major Adverse Events, a composite of:\n\n* Device-related death within 48 hours\n* Major bleeding within 48 hours\n* Device-related AEs within 48 hours, including:\n* Clinical deterioration\n* Pulmonary vascular injury\n* Cardiac injury","48 hours",{"measure":14,"description":15,"timeFrame":12},"Efficacy Endpoint: Reduction in RV\u002FLV Ratio","Reduction in RV\u002FLV ratio from baseline to 48 hours or discharge by CT angiography",[17,20,24,27,30,33,37,40,43,46,50,53,56,59,62,65,68,71,74],{"measure":18,"description":19,"timeFrame":12},"Safety Endpoint: Device-Related Death","Device-related death within 48 hours",{"measure":21,"description":22,"timeFrame":23},"Safety Endpoint: Major Bleeding","Major bleeding within 48 hours","48 Hours",{"measure":25,"description":26,"timeFrame":23},"Safety Endpoint: Device-Related Clinical Deterioration","Device-related clinical deterioration within 48 hours",{"measure":28,"description":29,"timeFrame":23},"Safety Endpoint: Device-Related Pulmonary Vascular Injury","Device-related pulmonary vascular injury within 48 hours",{"measure":31,"description":32,"timeFrame":23},"Safety Endpoint: Cardiac Injury","Cardiac injury within 48 hours",{"measure":34,"description":35,"timeFrame":36},"Safety Endpoint: Any-Cause Mortality","Any-cause mortality within 30 days","30 Days",{"measure":38,"description":39,"timeFrame":36},"Safety Endpoint: Device-Related Serious Adverse Event","Device-related Serious Adverse Events (SAEs) within 30 days",{"measure":41,"description":42,"timeFrame":36},"Safety Endpoint: Symptomatic Recurrence of Pulmonary Embolism","Symptomatic recurrence of Pulmonary Embolism (PE) within 30 days",{"measure":44,"description":45,"timeFrame":23},"Efficacy Endpoint: Modified Miller Index Score","Change in modified Miller Index Score (MMIS) between baseline and 48 hours post-procedure as assessed by CTA",{"measure":47,"description":48,"timeFrame":49},"Efficacy Endpoint: Change in Mean Pulmonary Artery Pressure","Change in mean pulmonary artery pressure measured invasively in the central pulmonary arteries before vs. after the endovascular procedure \\[measured in mmHg\\]","Procedure",{"measure":51,"description":52,"timeFrame":49},"Efficacy Endpoint: Procedural Change in Cardiac Index","Procedural change in cardiac index \\[measured in L\u002Fmin\u002Fm\\^2\\]",{"measure":54,"description":55,"timeFrame":36},"Efficacy Endpoint: Length of ICU Stay, Associated with Index Procedure","Length of stay in the ICU associated with the index procedure \\[measured in days\\]",{"measure":57,"description":58,"timeFrame":36},"Efficacy Endpoint: Length of Total Hospital Stay","Length of total hospital stay \\[measured in days\\]",{"measure":60,"description":61,"timeFrame":36},"Efficacy Endpoint: Post-Index Procedure Hospital Length of Stay","Post-index-procedure hospital length of stay \\[measured in days\\]",{"measure":63,"description":64,"timeFrame":49},"Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Mean Pressure","Procedural reduction in pulmonary artery mean pressure \\[measured in mmHg\\]",{"measure":66,"description":67,"timeFrame":49},"Efficacy Endpoint: Procedural Reduction in Pulmonary Artery Systolic Pressure","Procedural reduction in pulmonary artery systolic pressure \\[measured in mmHg\\]",{"measure":69,"description":70,"timeFrame":49},"Efficacy Endpoint: Reduction in Total Pulmonary Vascular Resistance","Procedural reduction in total pulmonary vascular resistance \\[measured in mmHg ⋅ min\u002FL\\]",{"measure":72,"description":73,"timeFrame":23},"Efficacy Endpoint: Change from Baseline in Dyspnea Severity by mMRC Score","Change from baseline in Dyspnea severity by mMRC score at the 48-hour visit",{"measure":72,"description":75,"timeFrame":36},"Change from baseline in Dyspnea severity by mMRC score \\[Time Frame: at the 30 days visit\\]",null,{"allocation":78,"interventionModel":79,"interventionModelDescription":76,"primaryPurpose":80,"observationalModel":76,"timePerspective":76,"maskingInfo":81},"NA","SINGLE_GROUP","DEVICE_FEASIBILITY",{"masking":82,"maskingDescription":76,"whoMasked":76},"NONE","The study objective is to evaluate the safety and effectiveness of the Vibrato™ Aspiration System Aspiration System (hereafter referred to as Vibrato™ Aspiration System) for aspiration mechanical thrombectomy in the treatment of acute PE.\n\nThe Vibrato™ Aspiration System is a vibration-assisted aspiration thrombectomy device including attributes designed to improve trackability, maintain a low-profile configuration, and operate without capital equipment. In addition, the Vibrato™ Aspiration System features a novel vibrating distal tip designed to enhance thrombus removal during aspiration while minimizing vascular injury. The vibrating mechanism may reduce procedure times, improve clot removal efficiency, and decrease the need for adjunctive interventions.",[85],{"label":86,"type":87,"description":88,"interventionNames":89},"Single arm study","EXPERIMENTAL","Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute pulmonary embolism.",[90],"Device: Mechanical Thrombectomy",[92],{"type":93,"name":94,"description":95,"armGroupLabels":96,"otherNames":76},"DEVICE","Mechanical Thrombectomy","Mechanical Thrombectomy for the treatment of Acute Pulmonary Embolism",[86],[98,103],{"name":99,"role":100,"phone":101,"phoneExt":76,"email":102},"Shawn M Patterson","CONTACT","7164323545","spatterson@egrethealthcareventure.com",{"name":104,"role":100,"phone":105,"phoneExt":76,"email":106},"Erin M Garcia","716-863-2552","egarcia@egrethealthcareventures.com",[108,126],{"facility":109,"status":110,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"Uniwersytet Medyczny im. Karola Marcinkowskiego w Poznaniu Uniwersytecki Szpital Kliniczny","NOT_YET_RECRUITING","Poznan","Greater Poland Voivodeship","61-848","Poland","PL",{"type":117,"coordinates":118},"Point",[119,120],16.92993,52.40692,{"lat":120,"lon":119},[123],{"name":124,"role":125,"phone":76,"phoneExt":76,"email":76},"Aleksander Araszkiewicz, Professor, MD, PhD","PRINCIPAL_INVESTIGATOR",{"facility":127,"status":128,"city":129,"state":130,"zip":131,"country":114,"countryCode":115,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Krakowski Szpital Specjalistyczny im. św. Jana Pawła II","RECRUITING","Krakow","Lesser Poland Voivodeship","31-202",{"type":117,"coordinates":133},[134,135],19.93658,50.06143,{"lat":135,"lon":134},[138],{"name":139,"role":125,"phone":76,"phoneExt":76,"email":76},"Grzegorz Kopeć, Professor, MD, PhD",{"type":141,"investigatorFullName":76,"investigatorTitle":76,"investigatorAffiliation":76,"oldNameTitle":76,"oldOrganization":76},"SPONSOR",[143],{"name":144,"class":145},"KCRI","OTHER","100646889","vibrato-aspiration-system---simple-intuitive-approach-to-clot-removal-in-acute-pulmonary-embolism---a-safety--feasibility-study-100646889",false,"NCT07685522","Vibrato Aspiration System - Simple, Intuitive Approach to Clot Removal in Acute Pulmonary Embolism - a Safety & Feasibility Study","Inclusion Criteria:\n\nSubjects must meet all following general inclusion criteria:\n\n1. Age ≥ 18 and ≤ 75 years.\n2. Clinical signs, symptoms, and presentation consistent with acute PE;\n3. PE symptom duration ≤ 14 days;\n4. CTA evidence (site determined) of proximal PE (filling defect in at least one main or interlobar pulmonary artery)\n5. RV\u002FLV ratio of ≥ 0.9 on CTA as assessed by investigator (site determined).\n6. Systolic blood pressure ≥ 90 mmHg;\n7. Stable heart rate \\\u003C 130 BPM prior to procedure;\n8. Patient is deemed medically eligible for interventional procedure(s), per institutional guidelines and clinical judgment\n9. Informed Consent Form signed\n10. Subject is willing and able to comply with all Clinical Investigation Plan required follow-up visit\n\nExclusion Criteria:\n\nSubjects must not meet any of the following general exclusion criteria:\n\n1. Thrombolytic use within 30 days of baseline CT angiogram\n2. Pulmonary hypertension with peak pulmonary artery pressure \\> 70 mmHg by right heart catheterization (site determined)\n3. Vasopressor requirement after fluids to keep pressure ≥ 90 mmHg;\n4. FiO2 requirement \\> 40% or \\> 6 LPM to keep oxygen saturation \\> 90%;\n5. Hematocrit \\\u003C 28%;\n6. Platelets \\\u003C 100,000\u002FML;\n7. Serum creatinine \\> 1.8 mg\u002FdL;\n8. International normalized ratio (INR) \\> 3;\n9. Major trauma injury severity score (ISS) \\> 15 within the past 14 days\n10. Presence of intracardiac lead in the right ventricle or right atrium placed within 6 months, Pacemaker or Implantable Cardioverter Defibrillators;\n11. Cardiovascular or pulmonary surgery within last 7 days;\n12. Actively progressing cancer requiring chemotherapy\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 uncompensated 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. Patients who are under intubation\n22. Any contraindication to systemic or therapeutic doses of heparin or anticoagulants;\n23. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated;\n24. Imaging evidence or other evidence that suggests, in the opinion of the Investigator, the Subject is not appropriate for mechanical thrombectomy intervention;\n25. Life expectancy of \\\u003C 90 days, as determined by Investigator;\n26. Female who is pregnant or nursing;\n27. Current participation in another investigational drug or device treatment study\n28. History of Hemorrhagic or Ischemic Stroke, including Transient Ischemic Attack, within last 90 days\n29. Current or history of chronic thromboembolic pulmonary hypertension (CTEPH) or chronic thromboembolic disease (CTED) diagnosis","ALL","18 Years","75 Years",{"count":156,"type":157},10,"ESTIMATED","INTERVENTIONAL",[78],"The study is a prospective, single-arm, multicenter study to evaluate the safety and effectiveness of the Vibrato™ Aspiration System for aspiration mechanical thrombectomy in the treatment of acute PE. This is the First in Man clinical study.",[162],"Pulmonary Embolism Acute",[164,165,166],"Pulmonary Embolism","Clot","DVT","2026-08-23",{"date":169,"type":170},"2026-08-25","ACTUAL",{"date":172,"type":157},"2026-08-21",{"date":174,"type":157},"2026-12",{"name":5,"class":6},2]