[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vascular-system-injuries\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vascular-system-injuries":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,56],{"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":31,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100650133","comparing-suture-vs-combined-closure-strategies-for-large-blood-vessel-access-in-patients-undergoing-transcatheter-aortic-valve-implantation-tavi-100650133",false,"NCT07743697","Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)","SEAL-TAVI - Suture vs combinEd Closure strAtegies in Large-bore Access After TAVI","SEAL-TAVI","Inclusion Criteria:\n\n* Patient is at least 18 years of age at the time of screening.\n* Patient is scheduled to undergo elective transcatheter aortic valve implantation (TAVI) via transfemoral arterial access.\n* Patient is deemed suitable for transfemoral TAVI and large-bore vascular access closure by the local Heart Team.\n* Patient (or legally authorized representative) provides written informed consent prior to initiating any study-related procedures.\n* Patient is willing and able to comply with all specified study procedures, follow-up visits, and clinical evaluations.\n\nExclusion Criteria:\n\n* Planned TAVI procedure via non-femoral arterial access (e.g., transapical, transaortic, subclavian\u002Faxillary, or carotid access).\n* Emergency or non-elective TAVI procedure.\n* Target main femoral artery vessel diameter, calcification, or tortuosity judged unsuitable for standard percutaneous large-bore vascular closure device deployment.\n* Known active, unresolved local or systemic infection at the planned vascular access site.\n* Known severe allergy or hypersensitivity to bovine tissue, collagen, or any component of the study closure devices (Perclose ProGlide\u002FProStyle or Angio-Seal) that cannot be adequately premedicated.\n* Severe bleeding diathesis, active major bleeding, or absolute contraindication to standard periprocedural anticoagulation or antiplatelet therapy.\n* Concurrent participation in another interventional clinical trial investigating cardiovascular devices or drugs that could confound study endpoints.\n* Patient is pregnant or breastfeeding.\n* Patient belongs to a vulnerable population (e.g., individuals deprived of liberty, under guardianship, or unable to give informed consent).","ALL","18 Years",{"count":20,"type":21},705,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to compare two strategies for closing the main artery access site in adult patients undergoing transcatheter aortic valve implantation (TAVI) through a blood vessel in the leg (transfemoral access).\n\nThe main questions it aims to answer are:\n\nDoes using a single suture device lower the rate of access-related vascular complications compared to using a hybrid combination of a suture device and a plug-based closure device? How do the two closure strategies compare regarding bleeding complications, procedure time, and time to complete vessel sealing?\n\nResearchers will compare a single-suture closure strategy to a hybrid closure strategy (one suture plus one plug-based device) to see if using a single suture reduces vessel-related complications and improves patient safety after TAVI.\n\nParticipants will:\n\nUndergo standard pre-procedure screening and TAVI via the main artery in the leg as part of routine medical care.\n\nReceive an initial single-suture placement before the large TAVI delivery system is inserted.\n\nBe evaluated after sheath removal for initial bleeding control; qualifying participants will then be randomly assigned (1:1) to either receive no additional device (single suture group) or receive a plug-based closure device (hybrid group).\n\nHave their heart and access site monitored during hospitalization, including laboratory checks and imaging prior to discharge.\n\nComplete a 72-hour safety and complication evaluation.",[27,28,29,30],"Aortic Valve Stenosis","Postoperative Complications","Vascular System Injuries","Hemorrhage",[15,32,33,34,35,36,37,38,39,40,41,42],"Transcatheter Aortic Valve Implantation","TAVI","Vascular Closure Device","Suture-Based Closure","Angio-Seal","ProGlide","ProStyle","Large-Bore Access","Vascular Complications","TAVR","Transcatheter Aortic Valve Replacement","NOT_YET_RECRUITING","2026-07-29",{"date":46,"type":47},"2026-08-04","ACTUAL",{"date":49,"type":21},"2026-10-01",{"date":51,"type":21},"2028-09",{"name":53,"class":54},"University Hospital, Basel, Switzerland","OTHER",1,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":63,"targetDuration":4,"studyType":65,"phases":4,"briefSummary":66,"conditions":67,"keywords":81,"overallStatus":91,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":55},"100434493","developing-a-decision-instrument-to-guide-abdominal-pelvic-ct-imaging-of-blunt-trauma-patients-100434493","NCT04937868","Developing a Decision Instrument to Guide Abdominal-pelvic CT Imaging of Blunt Trauma Patients","NEXUS AP CT","Inclusion Criteria:\n\nBlunt trauma patients who undergo abdominal-pelvic CT imaging during their initial trauma evaluation in the emergency department.\n\nExclusion Criteria:\n\nNone",{"count":64,"type":21},12000,"OBSERVATIONAL","Unrecognized abdominal and pelvic injuries can result in catastrophic disability and death. Sporadic reports of \"occult\" injuries have generated concern, and physicians, fearing that they may miss such an injury, have adopted the practice of obtaining computed tomography on virtually all patients with significant blunt trauma. This practice exposes large numbers patients to dangerous radiation at considerable expense, while detecting injuries in a small minority of cases.\n\nExisting data suggest that a limited number of criteria can reliably identify blunt injury victims who have \"no risk\" of abdominal or pelvic injuries, and hence no need for computed tomography (CT), without misidentifying any injured patient. It is estimated that nationwide implementation of such criteria could result in an annual reduction in radiographic charges of $75 million, and a significant decrease in radiation exposure and radiation induced malignancies.\n\nThis study seeks to determine whether \"low risk\" criteria can reliably identify patients who have sustained significant abdominal or pelvic injuries and safely decrease CT imaging of blunt trauma patients. This goal will be accomplished in the following manner:\n\nAll blunt trauma victims undergoing computed tomography of the abdomen\u002Fpelvis in the emergency department will undergo routine clinical evaluations prior to radiographic imaging. Based on these examinations, the presence or absence of specific clinical findings (i.e. abdominal\u002Fpelvic\u002Fflank pain, abdominal\u002Fpelvic\u002Fflank tenderness, bruising abrasions, distention, hip pain, hematuria, hypotension, tachycardia, low or falling hematocrit, intoxication, altered sensorium, distracting injury, positive FAST imaging, dangerous mechanism, abnormal x-ray imaging) will be recorded for each patient, as will the presence or absence of abdominal or pelvic injuries. The clinical findings will serve as potential imaging criteria. At the completion of the derivation portion of the study the criteria will be examined to find a subset that predicts injury with high sensitivity, while simultaneously excluding injury, and hence the need for imaging, in the remaining patients. These criteria will then be confirmed in a separate validation phase of the study.\n\nThe criteria will be considered to be reliable if the lower statistical confidence limit for the measured sensitivity exceeds 98.0%. Potential reductions in CT imaging will be estimated by determining the proportion of \"low-risk\" patients that do not have significant abdominal or pelvic injuries.",[68,69,70,71,72,73,74,75,76,77,78,79,29,80],"Abdominal Injury","Pelvic Fracture","Genital Hemorrhage","Lumbar Spine Injury","Hip Injuries","Liver Injury","Spleen Injury","Renal Injury","Diaphragm Injury","Aortic Rupture","Aortic Dissection","Bowel Disease","Sacral Fracture",[82,83,84,85,86,87,88,89,90],"Blunt trauma","Abdominal injury","Pelvic injury","Spine injury","Genital injury","Vascular injury","Hip injury","Computed tomography","Decision instrument","RECRUITING","2026-01-09",{"date":94,"type":47},"2026-01-13",{"date":96,"type":47},"2018-01-15",{"date":98,"type":21},"2027-06-15",{"name":100,"class":54},"University of California, Los Angeles"]