[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"valve-stenoses-aortic\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:valve-stenoses-aortic":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100537977","secondary-access---femoral-or-radial-in-transcatheter-aortic-valve-implantation-100537977",false,"NCT06284837","Secondary Access - FEmoral or Radial in Transcatheter Aortic Valve Implantation?","SAFER-TAVI","Inclusion Criteria:\n\n* Age \\>18 years\n* Undergoing transfemoral TAVI with any commercially available transcatheter heart valve\n* Suitable radial and secondary femoral access\n\nExclusion Criteria:\n\n* Primary arterial access via surgical cut-down\n* Inadequate contralateral femoral artery access and\u002For bilateral radial artery access as determined by the interventional cardiologist\n* Previously failed attempt to access bilateral radial arteries.\n* Patient on hemodialysis","ALL","18 Years",{"count":19,"type":20},542,"ESTIMATED","INTERVENTIONAL",[23],"NA","Transcatheter aortic valve implantation (TAVI) is a well-known safe and effective treatment for anatomically suitable patients with severe aortic stenosis (AS). Despite rapid improvements in TAVI technique and technology, vascular and bleeding complications from both primary and secondary access sites remain significant, with approximately 25% of access related complications thought to be related to secondary access. The transfemoral route remains the most common approach for primary access during TAVI due to proven safety and efficacy. Secondary access during TAVI, which is needed for angiographic guidance, has drawn little attention in randomised trials of TAVI. In coronary intervention, the radial approach is now preferred due to high quality evidence suggesting lower bleeding and vascular complications compared to the femoral approach. Whilst randomised control trials comparing radial vs femoral as secondary access are lacking in the TAVI setting, observational studies comparing the two secondary access routes have shown a lower risk of bleeding and vascular complications with radial compared to femoral access. A systematic review of all the major observational trials also suggests that radial access might reduce risk of bleeding, vascular complications, and even 30-day mortality, but these data are limited to observational trials and there are no randomised controlled data to confirm these findings. Accordingly, we aim to undertake a multicentre, randomised controlled trial among patients undergoing transfemoral TAVI to assess if radial secondary access is superior to femoral secondary access.",[26],"Valve Stenoses, Aortic",[28,29,30,31,32,33,34,35],"TAVI","TAVR","transcatheter aortic valve replacement","transcatheter aortic valve implantation","aortic stenosis","vascular access","primary access","secondary access","RECRUITING","2026-05-12",{"date":39,"type":40},"2026-05-14","ACTUAL",{"date":42,"type":40},"2023-12-04",{"date":44,"type":20},"2026-08",{"name":46,"class":47},"The Alfred","OTHER",3,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":75,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":5},"100586678","prophylactic-suture-line-sealing-with-nex-glue-r-eco-in-cardiac-and-vascular-surgery-100586678","NCT06918496","Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery","A Prospective ClinicaL investigatiOn Evaluating Prophylactic Sealing of sUture Lines Using the NE'X Glue R-eco Surgical AdhesivE in Cardiac and (Cardio)Vascular Anastomotic Repair Procedures","CLOSURE","Inclusion Criteria:\n\n* Patient ≥ 18 years of age at study entry.\n* Patient is scheduled for open procedures for surgical placement of a prosthetic or biologic graft (patch) or an allograft for cardiac and (cardio)vascular anastomosis repair. Emergency, transplantation and minimally invasive procedures are excluded. Patients receiving long-term anticoagulation, including antiplatelet agent, are included. Choice of graft is at the discretion of the surgeon.\n* Patient is willing and able to be contacted for up to 3 months (± 14 days) follow-up.\n* Patient or legal representative and investigator signed and dated the informed consent form prior to the index-procedure.\n\nExclusion Criteria:\n\n* Patient has a known hypersensitivity, contraindication, or allergic reaction to albumin or glutaraldehyde.\n* Patient has a history of bleeding diathesis or coagulopathy.\n* Presence of active infection or contamination in the to be grafted area or the vicinity.\n* Known vasculitis in the to be grafted area.\n* Patient takes immune suppressive medication like prednisone resulting in weakening of the vessel wall.\n* Patient is refusing blood transfusion.\n* Patient or legal representative is unable \u002F unwilling to provide informed consent.\n* Patient is unable to comply with the protocol or proposed follow-up visits.\n* Female patient is pregnant, lactating, or planning pregnancy during the clinical investigation.\n* Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release, abstinence).\n* Patients who are currently enrolled in another clinical study, or have recently participated in a clinical study, that could potentially interfere with the outcomes or introduce bias into the results of the current study (as determined by the investigator). This includes studies involving investigational drugs, medical devices, or other interventions that could impact the safety, efficacy, or scientific integrity of this study.",{"count":58,"type":20},60,[23],"This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a prosthetic or biologic graft, patch, or allograft.\n\nThe effectiveness of the adhesive will be assessed after restoring blood flow.",[62,63,26,64,65,66,67,68,69,70,71,72,73,74],"Aortic Aneurysm","Aortic Aneurysm Abdominal","Valve Regurgitation, Mitral","Valve Regurgitation, Tricuspid","Aneurysm of Ascending Aorta","Aneurysm Abdominal","Artery Diseases, Peripheral","Ventricular Aneurysm","Coronary Artery Disease","Valve Aortic Regurgitation","Aortic Aneurysms Arch","Aortic Aneurysms Descending","Aortic Aneurysms Thoracoabdominal",[76,77,78,79,80],"prophylactic sealing of suture lines","Surgical glue","cardiac and (cardio)vascular anastomotic repair procedures","grafts","NE'X Glue R-eco surgical adhesive","NOT_YET_RECRUITING","2025-04-08",{"date":84,"type":40},"2025-04-09",{"date":86,"type":20},"2025-06-30",{"date":88,"type":20},"2026-03-31",{"name":90,"class":91},"Grena Biomed Limited","INDUSTRY"]