[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vascutek Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":137},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,57,82,114],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"100598968","a-study-to-evaluate-the-safety-and-effectiveness-of-the-rapidlink-device-when-used-in-patients-undergoing-an-open-surgical-procedure-to-repair-the-aorta-100598968",false,"NCT07078383","A Study to Evaluate the Safety and Effectiveness of the Rapidlink Device When Used in Patients Undergoing an Open Surgical Procedure to Repair the Aorta","Evaluation of the Rapidlink Device for Use in the Repair or Replacement of the Supra-Aortic Vessels During an Open Surgical Procedure of the Thoracic Aorta","RAPID","Inclusion Criteria:\n\n* Patient is aged 18 years or over on date of consent\n* Written informed consent (from patient or a legally authorized representative) to participate in study, documenting willingness and ability to comply with all study procedures and study visits (unless an exemption for emergency cases has been IRB \u002F EC approved)\n* Patient's need for open surgical repair of the thoracic aorta using a Gelweave graft or a Thoraflex Hybrid device (AnteFlo or Plexus) in line with the applicable IFU\n* Anticipated need to use Rapidlink for the repair or replacement of the LSA, LCCA and\u002For IA during the open surgical repair\n* Patient has an 8-15 mm inner diameter (target SAV)\n* The diameters of the patient's target supra-aortic vessel(s), fall within the ranges specified in the IFU\n\nExclusion Criteria:\n\n* Patient does not have a clear landing zone equal to the implantable stent length which is free from stenosis, calcification or thrombus.\n* Patient does not have a sealing zone free from tortuosity.\n* Patient has significant angulation (\\>79° with an internal radius of less than 6mm) for the full implantable stent length\n* Patient cannot receive anticoagulation \u002F antiplatelet therapy during or after the index procedure as per the protocol\n* Patient has uncontrolled hypercoagulation\n* Patient has a condition which may compromise or prevent the necessary imaging requirements\n* Patient has anatomic variants which would compromise circulation to the first branch off the target artery after placement of the Rapidlink device (unless planned and\u002For otherwise revascularized)\n* Patient is unfit for open surgical repair involving circulatory arrest per the study investigator\n* Patient has known sensitivity to polyester, nitinol, tantalum, or materials of bovine origin\n* Patient has a ruptured aorta\n* Patient has active endocarditis or an active infective disorder of the aorta\n* Patient has an active systemic infection that, in the opinion of the investigator, would compromise the outcome of the surgical procedure\n* Patient is enrolled in another active study and has received an investigational product (device, pharmaceutical or biologic) within 6 months prior to the date of the implant or has not reached the primary endpoint of the study\n* Patient is female and is pregnant or planning to become pregnant during the course of the study. Females of childbearing potential must use acceptable methods of contraception during the course of the study.\n* Patient has an uncorrectable bleeding anomaly\n* Patient has renal failure (defined as dialysis dependent or serum creatinine ≥2.5mg\u002FdL)\n* Patient has known sensitivity to radiopaque contrast agents that cannot be adequately pre-treated\n* Patient has a co-morbidity causing expected survival to be less than 1 year\n* Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre and post procedure\n* Patient has a known chronic aortic dissection involving the intended landing zone of the target supra-aortic vessel(s)","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24],"NA","The Goal of this Clinical Study is to evaluate the safety and effectiveness of the Rapidlink device in the repair or replacement of the supra-aortic vessels during open surgical repair of aortic disease affecting the thoracic aorta.\n\nThis study will collect information on patients who are already having surgery to repair their aorta and who will have Rapidlink device implanted into one or more of the aortic arch vessels.\n\nThe first 32 subjects enrolled will undergo left subclavian artery repair or replacement, only, with the Rapidlink device. After the 32nd subject, enrollment will proceed to include subjects undergoing any supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and\u002For innominate artery) repair or replacement with the Rapidlink device in a planned surgery.\n\nAfter the 32nd subject is enrolled in the main group, up to 30 subjects will undergo supra-aortic vessel (i.e., left subclavian artery, left common carotid artery, and\u002For innominate artery) repair or replacement with the Rapidlink device in an emergency setting.\n\nData will be collected before, during and after surgery including recovery at discharge, 30 days, 6 months, 1 and 2 years after the surgery.",[27,28,29,30,31,32],"Aortic Aneurysm","Aortic Aneurysm and Dissection","Aortic Diseases","Aneurysm of Aorta, Thoracic","Aneurysmal Disease","Aorta, Thoracic Pathologies",[34,35,36,37,38,39,40,41,42,43],"Vascular Prosthesis","Replacement or bypass of disease vessels","aneurysmal disease","Aortic branch vessels","Open aortic arch repair","aneurysm","dissection","Supra-aortic Vessels","Frozen Elephant Trunk","Left Subclavian Artery","RECRUITING","2026-07-01",{"date":47,"type":48},"2026-07-02","ACTUAL",{"date":50,"type":48},"2025-12-19",{"date":52,"type":21},"2028-11",{"name":54,"class":55},"Vascutek Ltd.","INDUSTRY",22,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100381427","terumo-aortic-global-endovascular-registry-100381427","NCT04246463","Terumo Aortic Global Endovascular Registry","A Global Post Market Evaluation of Terumo Aortic Endovascular Grafts","TiGER","Inclusion Criteria:\n\n* Minimum age as per local regulations\n* Indication for aortic endovascular repair with an approved or CE marked by a Regulatory body or custom-made Terumo Aortic Endovascular graft\n* Ability to provide informed consent\n\n  o Emergent cases (typically younger patients with traumatic injuries) are not excluded if there is IRB\u002FEC agreement to allow consent after intervention (i.e. consent to study participation, not to treatment) or use of a Legally Authorized Representative (LAR).\n* Willingness to comply with the registry protocol\n* Willingness to adhere to follow-up visits Note: Patients currently enrolled and actively participating within the TREO registry (IP-0020-16) can have their data migrated from TREO to the TiGER registry where local EC approval has been obtained and the patient has been reconsented to TiGER for longer follow-up.\n\nExclusion Criteria:\n\nPatient is unable or unwilling to comply with the study follow-up regime. Patient is contraindicated per the IFU, or has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving treatment as well as the procedures and evaluations pre and post procedure.",{"count":66,"type":21},1000,"OBSERVATIONAL","Multi-arm, multi-center, open label, prospective observational registry designed to obtain safety and performance data on the use of CE marked and custom Terumo Aortic endovascular grafts.",[70,71,72],"Abdominal Aortic Aneurysm","Thoracic Aortic Aneurysm","Surgery","2026-03-10",{"date":75,"type":48},"2026-03-13",{"date":77,"type":48},"2019-12-17",{"date":79,"type":21},"2030-11",{"name":54,"class":55},58,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":90,"targetDuration":92,"studyType":67,"phases":4,"briefSummary":93,"conditions":94,"keywords":103,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},"100404373","panther-study-of-terumo-aortic-knitted-and-woven-grafts-and-cardiovascular-patches-100404373","NCT04545502","PANTHER Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches","A Prospective and Retrospective, Multi-Centre, Post-Market, Non-Interventional Study of Terumo Aortic Knitted and Woven Grafts, and Cardiovascular Patches","PANTHER","Inclusion Criteria:\n\n* Patients must meet all of the following inclusion criteria in order to be eligible for inclusion in the study:\n\nAll Patients:\n\n* Patient meets the minimum age as per local regulations at time of consent\n* Patient requires treatment with study device(s) according to the IFU(s)\n* Patient is willing and able to comply with all SOC procedures and study visits\n* Patient or their legally authorised representative (LAR) has given written informed consent to participate in study, including consent to collect data retrospectively\n\n  * For prospective emergency patients, retrospective consent is permissible\n  * For retrospective patients who are deceased at time of enrollment, local EC regulations relating to consent process should be followed.\n\nRetrospective Patients only:\n\n* Patient has a minimum of 1 year post-operative follow-up data available, or complete data to death.\n* Patient implant date is no more than 5 years prior to study start date.\n\nExclusion Criteria:\n\n* Any patient who meets any of the following exclusion criteria will be excluded from participation in the study:\n\n  * Patient is unable or unwilling to comply with the SOC procedures or follow-up regime\n  * Patient is contraindicated per the device IFU\n  * Patient has any other medical, social or psychological problems that in the opinion of the investigator preclude them from receiving this treatment and the procedures and evaluations pre- and post-procedure",{"count":91,"type":21},2000,"10 Years","The purpose of this registry is to collect safety and performance data on all commercially available Terumo Aortic knitted and woven grafts, and cardiovascular patches in standard clinical practice.\n\nData will be collected both retrospectively and prospectively.",[95,96,97,98,99,100,101,102,29],"Aneurysm","Dissection","Aortic Root Aneurysm","Aortic Root Dissection","Carotid Artery Injuries","Aortic Arch","Bypass Extremity Graft","Occlusive Vascular Disease",[104],"Vascular Surgery","2025-05-28",{"date":107,"type":48},"2025-06-03",{"date":109,"type":48},"2021-02-17",{"date":111,"type":21},"2037-01",{"name":54,"class":55},31,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":11,"sex":17,"minAge":121,"maxAge":4,"enrollmentInfo":122,"targetDuration":124,"studyType":67,"phases":4,"briefSummary":125,"conditions":126,"keywords":4,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100584791","technical-evaluation-and-results-of-the-use-of-treo-modular-aortic-endografts-for-the-treatment-of-abdominal-aortic-aneurysms-100584791","NCT06893952","Technical Evaluation and Results of the Use of TREO® Modular Aortic Endografts for the Treatment of Abdominal Aortic Aneurysms","RegisTREO","Inclusion Criteria:\n\n1. Patient who has confirmed his\u002Fher non-opposition to the use of his\u002Fher data in the study.\n2. Patient aged 45 years or older.\n3. Patient with AAA with one of the following criteria:\n\n   * Maximum diameter ≥50 mm for women and ≥55 mm for men\n   * Rapid growth (≥5 mm in 6 months or ≥10 mm in 12 months)\n   * Unruptured AAA with clinical symptoms of abdominal pain\n4. Adequate anatomy for TREO® stent graft implantation, including:\n\n   * Adequate iliac and femoral arteries for the modular system\n   * Suprarenal angle less than 45 degrees\n   * Infrarenal aortic neck greater than or equal to 10 mm in length with an angle less than 60° and an internal diameter of 17mm-32mm, or an infrarenal aortic neck greater than or equal to 15 mm in length with an angle between 60 and 75° and an internal diameter of 16mm-30mm\n   * Distal iliac sealing distance ≥ 10 mm and an iliac diameter between 8-13 mm or a distal iliac sealing distance ≥ 15 mm and a diameter between 13-21 mm\n5. Ability to follow the entire protocol from 1 to 60 months\n6. Life expectancy greater than 2 years\n\nExclusion Criteria:\n\n1. Patients refusing treatment and follow-up as part of the study\n2. Infected or ruptured aneurysm\n3. Associated aortic lesion (thoracic or thoracoabdominal aneurysm) requiring management\n4. Renal failure defined by creatinine \\> 2.5 mg\u002FdL or patient in pre-dialysis status and impossibility of intervention with use of CO2 injection\n5. New York Heart Association (NYHA) class IV\n6. Aneurysmal, dissected distal implantation zone, or including calcifications and\u002For significant thrombus that could compromise sealing\n7. Tortuous iliac and\u002For femoral access and\u002For including calcified stenosis\n8. Systemic infection that could increase the risk of infection of the endoprosthesis\n9. Pathology of the supporting tissues such as collagenosis (Marfan or Ehler-Danlos, etc.)\n10. Known drug use\n11. Known sensitivity or allergy to the materials to be implanted\n12. Patients contraindicated for antiplatelet treatment\n13. Patients with an uncontrolled hematological disorder or heparin-induced thrombocytopenia\n14. Patients who are pregnant or planning to become pregnant\n15. Patients considered hemodynamically unstable or requiring emergency treatment\n16. Patients with severe arterial disease leading to a negative \"outflow\" that may degrade the permeability of implanted stents\n17. Scheduled hybrid aortic technique (surgical and endovascular)\n18. Patients with complex iliac access outside the manufacturer's indications and recommendations that may lead to procedural failure","45 Years",{"count":123,"type":21},209,"5 Years","This study is a clinical investigation as part of the post-market clinical follow-up of the TREO® abdominal aortic graft in its initial use, French, observational, multicenter, non-randomized, single-arm. Information on patient's health and the implanted device will be collected over a period of 5 consecutive years. The data collected will be analyzed on the technical success and the absence of major events (death, stroke, myocardial infarction, visceral ischemia, paraplegia, respiratory failure, renal failure, intraoperative blood loss, thromboembolic event) and possible reinterventions related to the patient's operation.",[127],"Aortic Aneurysm Abdominal","NOT_YET_RECRUITING","2025-03-18",{"date":131,"type":48},"2025-03-25",{"date":133,"type":21},"2025-04",{"date":135,"type":21},"2031-12",{"name":54,"class":55},""]