[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pseudoaneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pseudoaneurysm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,44,74,118,147,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":4},"100636337","mba-early-feasibility-study-100636337",false,"NCT07564375","MBA Early Feasibility Study","Early Feasibility Study of the GORE® Multibranch Arch Endoprosthesis (MBA Device)","Inclusion Criteria:\n\nThe subject is \u002F has:\n\n1. Thoracic pathologies with involvement of the arch branch vessels, that are compatible with the treatment requirements of the MBA device, and meeting any of the following criteria:\n\n   a) Aneurysm and Isolated Lesions: i. Fusiform aneurysm (≥ 55 mm or documented growth rate \\> 0.5 cm\u002Fyear). ii. Saccular aneurysm (no diameter criteria). iii. Pseudoaneurysms (\\> 30 days post-surgery, no diameter criteria). iv. Penetrating Aortic Ulcers (PAUs) without intramural hematoma (IMH) (no diameter criteria).\n\n   b) Aortic dissection: i. Uncomplicated and high-risk chronic de novo (\\> 90 days) Type B aortic dissection with primary entry tear in the arch or descending thoracic aorta.\n\n   ii. Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (\\> 30 days post-treatment).\n\n   iii. Proximal extension of prior endovascular repair (\\> 30 days post-treatment and \\> 90 days post-dissection) of a Type B dissection requiring treatment.\n\n   iv. Pseudoaneurysms, following open surgical repair of a Type A dissection (\\> 30 days post-surgery, no diameter criteria).\n2. Anatomic compatibility with MBA device and other devices required for proximal or distal extensions based on Gore's review.\n\n   1. Adequate vascular access via transfemoral or retroperitoneal approach.\n   2. Appropriate vascular access to allow for through-wire access to the brachiocephalic artery, LCCA, and LSA.\n   3. Proximal Aortic Landing Zone:\n\n   i. Landing zone is native aorta, surgical graft, or previously implanted GORE thoracic stent graft.\n\nii. Landing zone diameter between 27 mm - 48 mm. iii. Acceptable ascending aorta outer curvature length for the required MBA device.\n\n1. Proximal segment length (length from distal edge of brachiocephalic artery to distal edge of the most distal coronary artery) must be ≥ 2 cm longer than the \"AC Proximal End to BCA Portal Length\" for the selected Aortic Component or ≥ 3 cm if the landing zone is \\> 42 mm.\n2. For patients with patent bypass graft from the ascending aorta, proximal extent of landing zone must be ≥ 1 cm distal to the bypass graft.\n\niv. Lesion location is ≥ 2 cm distal to the most distal coronary artery ostium. v. For patients with an existing transcatheter aortic valve replacement (TAVR) there must be a sufficient proximal landing zone to avoid interference with the required MBA device (including any proximal extensions with the ASG device).\n\nvi. Proximal landing zone must be ≥ 2 cm in the ascending aorta.\n\n1. For patients with prior replacement of the ascending aorta and \u002F or aortic arch by surgical graft, there must be ≥ 2 cm overlap of MBA device and previously implanted graft.\n2. For patients with a de novo aortic dissection, the primary entry tear must be located ≥ 2 cm distal to the proximal extent of the MBA device (including any proximal extensions) and the proximal edge of the stent graft must land in non-dissected aorta.\n\n   vii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed.\n\n   d) Branch Vessel Landing Zone: i. Length of ≥ 2.5 cm proximal to first major branch vessel. ii. Target branch vessel inner diameter of 11-18 mm for the 12 mm portal, and 6-15 mm for the 8 mm portal.\n\n   iii. Target branch vessel landing zone must be in native aorta that cannot be heavily calcified, or heavily thrombosed.\n\n   iv. All three arch target vessels must have appropriate anatomy for cannulation (including through-wire access) and treatment with MBA branch components.\n\n   e) Distal Aortic Landing Zone (aneurysms and isolated lesions only): i. Outer curvature length must be ≥ 2 cm proximal to the celiac artery. ii. Aortic inner diameters between 16-42 mm. iii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed.\n\n   iv. Landing zone in native aorta, surgical graft, or previously implanted GORE thoracic stent graft.\n3. Age ≥ 18 years at time of informed consent signature.\n4. Informed Consent Form (ICF) signed by the subject or legally authorized representative (LAR), according to local regulation.\n5. Agrees to comply with protocol requirements, including imaging and five year (60 month) follow-up.\n6. Considered high-risk for open surgical repair by meeting one or more of the following criteria:\n\n   1. ≥ 75 years of age\n   2. Previous median sternotomy\n   3. Documented identification of other subject-specific risk factors (e.g., medical history, active medical diagnosis) by a study investigator and an experienced open ascending and \u002F or aortic arch surgeon (e.g., cardiothoracic surgeon).\n7. Considered high-risk for surgical debranching by meeting one or more of the following criteria:\n\n   1. Prior neck surgery or radiation\n   2. Neck anatomy \u002F body habitus impeding carotid access or safe bypass tunneling\n   3. Dysphagia\n   4. Elevated risk for post-operative infection (e.g., malnutrition, uncontrolled diabetes (hemoglobin A1c \\> 9%), current treatment with immunosuppressant therapy or chemotherapy)\n   5. Reduced pulmonary function (e.g., severe chronic obstructive pulmonary disease (COPD), current or anticipated tracheostomy)\n   6. Clinical Frailty Scale score 6-7\n   7. Documented identification of other subject-specific risk factors which would pose high risk for surgical debranching (e.g., medical history, active medical diagnosis) by a study investigator\n\nExclusion Criteria:\n\nThe subject is \u002F has:\n\n1. De novo Type A dissection\n2. Requires immediate treatment.\n3. Arch vessels with dissection extending into the intended landing zones.\n4. Anticipated need for coronary or aortic valve intervention within one year post-treatment.\n5. Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment.\n6. Complex percutaneous coronary intervention (PCI) within 30 days prior to treatment.\n7. Open chest surgical repair within 30 days prior to treatment.\n8. Any open or interventional repair of either carotid artery within 30 days prior to treatment.\n9. Presence of Intramural Hematoma (IMH) in landing zones.\n10. Prosthetic heart valve in the aortic position that precludes safe delivery of any study device.\n11. Aortic insufficiency (AI) grade 3 or greater.\n12. Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair.\n13. Concomitant vascular disease, including disease associated with the great and upper extremity vessels, requiring treatment that is not planned for index endovascular procedure.\n14. Any stroke or MI within 90 days prior to treatment.\n15. Presence of protruding and \u002F or irregular thrombus and \u002F or atheroma in the ascending aorta or aortic arch or any other factor that could increase the risk of stroke based on Gore's review.\n16. Any chronic condition that is not well controlled and that is known to increase stroke risk.\n17. Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome (EDS)).\n18. Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor.\n19. Known medical, social, or psychological issues that the Investigator believes may interfere with treatment or follow-up, such as a history of drug abuse within one year of treatment.\n20. Pregnant at time of procedure or planning to become pregnant within the first 12-months of participation in the study.\n21. Active infected aorta, mycotic aneurysm.\n22. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).\n23. Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 (mL\u002Fmin\u002F1.73 m2) or currently requiring dialysis.\n24. Life expectancy \\\u003C12 months.\n25. Known sensitivities or allergies to the device materials.\n26. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.\n27. Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta.\n28. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin or a history of a hypercoagulability disorder and \u002F or state.\n29. Severe Congestive Heart Failure (CHF) (New York Heart Association (NYHA) functional class IV).\n30. Acute Coronary Syndrome (ACS) including unstable angina.","ALL","18 Years",{"count":19,"type":20},20,"ESTIMATED","INTERVENTIONAL",[23],"NA","The MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.",[26,27,28,29],"Thoracic Aortic Aneurysm","Penetrating Aortic Ulcers (PAUs)","Thoracic Aortic Dissection","Pseudoaneurysm",[31],"MBA 25-04","NOT_YET_RECRUITING","2026-05-27",{"date":35,"type":36},"2026-06-01","ACTUAL",{"date":38,"type":20},"2026-09",{"date":40,"type":20},"2034-11",{"name":42,"class":43},"W.L.Gore & Associates","INDUSTRY",{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100631325","lymphatic-injury-visualization-in-vascular-surgery-100631325","NCT07499206","Lymphatic Injury Visualization in Vascular Surgery","Visualization and Treatment of Lymphatic Injury During Vascular Surgery Procedures in the Groin: A Pilot Study","LymphFistula-P","Inclusion Criteria:\n\n* adult patients undergoing vascular surgery procedures in the groin\n* signed informed consent for study participation\n\nExclusion Criteria:\n\n* pregnant or lactating women\n* prior groin surgery\n* infected surgical site in the groin\n* necessity for further incisions (e.g. bypass surgery)\n* incapability of judgement or consent","100 Years",{"count":54,"type":20},60,[23],"This study aims to assess a simple intervention: Visualization of lymphatic injury + treatment (in case of detection). This will generate data on the incidence of intraoperative lymphatic injury and the effect of treatment. This data will then hopefully enable a multi-center RCT to generate high level evidence on this matter.",[58,59,60,61,62,29],"Vascular Surgical Procedure","Peripheral Arterial Disease(PAD)","Acute Ischemia","Hemmorhage","Aneurysm","2026-03-23",{"date":65,"type":36},"2026-03-30",{"date":67,"type":20},"2026-04",{"date":69,"type":20},"2027-04",{"name":71,"class":72},"University Hospital, Basel, Switzerland","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":82,"targetDuration":84,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":96,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":117},"100629458","targeting-real-world-usage-in-stroke-treatment-100629458","NCT07474935","Targeting Real World Usage In Stroke Treatment","TRUST Registry - Targeting Real World Usage In Stroke Treatment A WallabyPhenox Hemorrhagic Stroke Registry","TRUST","Inclusion Criteria:\n\n* Subject treated or intended to be treated with at least one target registry device during the procedure (i.e., at least one attempt of introduction into the vasculature of the subject),\n* Non-opposition to data collection or informed consent provided by the subject or legal representative as per country-specific legislation.\n\nExclusion Criteria:\n\n* Participation in an interventional study modifying standard care management for all relevant indications,",{"count":83,"type":20},5000,"5 Years","OBSERVATIONAL","TRUST Registry is an observational, prospective, long-term, post-market surveillance registry of subjects treated with WallabyPhenox flow modulation devices, stent systems, bifurcation aneurysm implants including their HPC variants (Hydrophilic Polymer Coating) where applicable as well as coil systems, and other adjunctive medical devices.\n\nThe overarching purpose of this registry is to carry out a proactive gathering, recording, and analysis of data on the safety, performance and usability of the devices as applied within the routine practice of the participating registry sites.",[88,29,89,90,91,92,93,94,95],"Saccular and Fusiform Aneurysms","Vascular Dissection","Perforation","Bifurcation Aneurysms","Stenosis","Neurovascular Abnormalties","Wide-neck Aneurysm","Intracranial Aneurysms",[97,98,99,100,101,102,103,104,105,106],"TRUST Registry","Registry study","Flow Diverter","WallabyPhenox","p48 MW (HPC)","p64","Avenir Coil","p64 MW (HPC)","pEGASUS HPC","pCONUS 2 (HPC)","RECRUITING","2026-03-11",{"date":110,"type":36},"2026-03-16",{"date":112,"type":36},"2026-01-29",{"date":114,"type":20},"2041-01",{"name":116,"class":43},"Phenox GmbH",13,{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":124,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":126,"conditions":127,"keywords":132,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":73},"100591940","beacon-tip-sizing-catheter-and-slip-cath-beacon-tip-catheter-study-100591940","NCT06986954","Beacon Tip Sizing Catheter and Slip-Cath Beacon Tip Catheter Study","Inclusion Criteria:\n\n* A patient is deemed suitable for inclusion in this study if the patient undergoes a procedure using an applicable Beacon Tip Catheter.\n\nExclusion Criteria:\n\n* Patient or his\u002Fher legally authorized representative objects to collection and processing of his\u002Fher data, or not willing to accept the use of an Informed Consent waiver or the data protection notice (if utilized).",{"count":125,"type":20},588,"This prospective observational post-market clinical study will collect data in the United States to primarily support the re-launch of the re-designed Beacon Tip Sizing Catheter and Slip-Catheter Beacon Tip Catheter \\& Shuttle Select Slip-Catheter (Visceral and Cerbral) for a Conformité Européenne (CE) Mark application in the European Union (EU). Additionally, the data from this study may be used to support regulatory approval in other countries\u002Fregions.\n\nThe purpose of this clinical study is to evaluate the safety and performance of these catheters in accordance with the Intended Use through the end of index procedure, and through 30 days post procedure, (as applicable as data is available) to ensure an acceptable benefit:risk ratio.",[92,128,129,130,131,29],"Bleed Intracranial","Stroke","TIA","Vascular Malformation",[133,134,135,136,137],"Catheter","Beacon","Diagnostic imaging","Device sizing","Beacon tip slip cath","2025-07-15",{"date":140,"type":36},"2025-07-16",{"date":142,"type":36},"2025-04-20",{"date":144,"type":20},"2026-07-31",{"name":146,"class":43},"Cook Research Incorporated",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":153,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":73},"100568063","mechanical-complications-of-acute-myocardial-infarction-a-multicenter-prospective-study-100568063","NCT06676345","Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Study","Mechanical Complications of Acute Myocardial Infarction: a Multicenter Prospective Observational Study","CAUTION 2","Inclusion Criteria:\n\n* all the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned\n\nExclusion Criteria:\n\n* patients with cardiac rupture not acute myocardial infarction related",{"count":156,"type":20},800,"In 2019, the international study titled \"CAUTION Study - 1\" (MeChanical complicAtions of acUte myocardial infarcTion: an InternatiOnal multiceNter cohort study), a retrospective multicenter study, was launched and registered on ClinicalTrials.gov (Identifier: NCT03848429). This study highlighted the outcomes of surgical treatment of post-infarction mechanical complications in patients operated between 2000 and 2019. Several scientific publications have resulted from this registry, which involved 27 international centers and recruited about 800 patients. However, retrospective studies are inherently limited by factors such as selection bias and a high number of missing data, affecting data interpretation and consistency of results. Moreover, most registries report only data about surgical patients or, in rare situations, about patients treated percutaneously. To overcome these limitations, a prospective study has been designed to collect more precise and focused data and achieve results that better reflect the current clinical practice, including all the patients diagnosed with post-infarction mechanical complications, independently from the treatment assigned.\n\n\"CAUTION Study - 2\" is, therefore, a prospective, multicenter cohort study with the primary aim of analyzing the outcomes of surgical, percutaneous and conservative treatment of post-infarction mechanical complications in the contemporary era.",[159,160,161,29],"Ventricular Septal Defect","Papillary Muscle Rupture","Cardiac Rupture","2025-05-07",{"date":164,"type":36},"2025-05-11",{"date":166,"type":36},"2025-01-01",{"date":168,"type":20},"2032-12-31",{"name":170,"class":72},"Maastricht University Medical Center",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":107,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":196},"100224613","feasibility-of-endovascular-repair-of-ascending-aortic-pathologies-100224613","NCT02201589","Feasibility of Endovascular Repair Of Ascending Aortic Pathologies","Proposed Single Center Investigational Device Exemption: Feasibility of Endovascular Repair Of Ascending Aortic Pathologies","Inclusion Criteria:\n\n* Patient must have a Type A thoracic aortic dissection, retrograde Type A thoracic aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm of the ascending thoracic aorta affecting the area between the Sinus of Valsalva and the innominate artery orifice (with no involvement of the aortic valve) and be considered candidates for endovascular repair;\n* Patient must also have at least one cm proximal and distal landing zones in the ascending aorta between 28-44 mm in diameter;\n* The patient must be deemed high-risk surgical candidate according to the following established criteria: ASA (American Society of Anesthesiologists) class IV.\n\nExclusion Criteria:\n\n* Pregnant or pediatric patients (younger than 21 years of age);\n* Patients who have a condition that threatens to infect the stent graft\u002Faortic valve prosthesis;\n* Patients with allergies to the stent graft material;\n* Patients or their legally authorized representatives who do not sign the informed consent;\n* Patients with expected survival less than one year.",{"count":19,"type":20},[23],"The purpose of this study is to investigate the outcome of patients with pathologies of the ascending thoracic aorta (diseases in the great blood vessel or artery that leads away from the heart) including type A aortic dissection, retrograde type A aortic dissection, intramural hematoma, penetrating ulcer or pseudoaneurysm who are suitable for endovascular (within the vessel) repair with the Medtronic Valiant PS-IDE (Physician Sponsored-Investigational Device Exemption) Stent Graft. Type A aortic dissection is a condition where blood passes through the inner lining or between the layers of the blood vessel from a tear in the aortic wall (dissection) in the ascending aorta; a retrograde Type A aortic dissection is a condition where the dissection or tear in the ascending aorta starts from the descending aorta; an intramural hematoma is a collection of clotted blood within the aortic wall; a penetrating ulcer has a plaque or clot within the wall and a pseudoaneurysm is a false aneurysm . If left untreated in any of these conditions, the aorta can enlarge and rupture causing injury or death. The plan for these patients is to repair the ascending thoracic aorta using the Medtronic Valiant PS-IDE Stent Graft with the Captivia Delivery System. The Valiant Captivia has been evaluated worldwide and used extensively in patients with type B (descending) thoracic aortic dissection. Since the dissections in the ascending aortas mirror that of the descending aorta, it is expected that this stent graft will deliver similar performance and endurance in patients with type A aortic dissection. The investigators expect to reroute the blood to the true lumen (the inner space within the blood vessel) by covering the proximal (nearest to the heart) tear with the stent graft. The stent graft is a stent frame made from Nitinol wire and covered with an expandable material made of a polyester material. This new study will determine how well the device works to treat dissections, intramural hematomas, penetrating ulcers and pseudoaneurysms in the ascending thoracic aorta.",[182,183,184,29],"Aortic Dissection","Intramural Hematoma","Penetrating Ulcer",[186],"Lesions in the ascending thoracic aorta","2025-05-02",{"date":189,"type":36},"2025-05-06",{"date":191,"type":36},"2013-11",{"date":193,"type":20},"2033-12",{"name":195,"class":72},"Rodney A. White, MD",3]