[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"venous-stenosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:venous-stenosis":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,59,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":33,"overallStatus":47,"whyStopped":4,"lastUpdateSubmitDate":48,"lastUpdatePostDateStruct":49,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":4},"100634355","the-gore-viabahn-fortegra-venous-stent-post-approval-study-100634355",false,"NCT07538609","The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study","Preoperative Inclusion Criteria:\n\n* Presence of a lesion necessitating treatment with the GORE® VIABAHN® FORTEGRA Venous Stent, as previously determined by an investigator\u002Fsub-investigator.\n* Patient is at least 18 years of age.\n* Patient is willing and able to comply with all follow-up evaluations as well as any required medication or compression regimen.\n* Patient is able to provide informed consent themself.\n\nIntraoperative Inclusion Criteria:\n\n* Patient can accommodate an appropriately sized GORE® VIABAHN® FORTEGRA Venous Stent as per reference vessel diameter (see IFU), as determined by intraoperative IVUS post pre-dilation.\n* Patient must have appropriate access vessels to accommodate the delivery sheath for the selected device size.\n* Patient has adequate landing zones free from significant disease requiring treatment beyond the proximal and distal margins of the lesion.\n* Patient has adequate inflow\u002Foutflow to\u002Ffrom the target lesion(s), per investigator\u002Fsub- investigator discretion.\n* Lesion can be traversed with a guidewire.\n\nIntraoperative Exclusion Criteria:\n\n* Patient is contraindicated for treatment with the GORE® VIABAHN® FORTEGRA Venous Stent according to the IFU.","ALL","18 Years",{"count":18,"type":19},150,"ESTIMATED","INTERVENTIONAL",[22],"NA","This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.",[25,26,27,28,29,30,31,32],"Venous Thromboses","Venous Disease","Venous Leg Ulcer","Venous Stasis","Venous Ulcer","Venous Stenosis","Venous Occlusion","Vein Thrombosis",[34,35,36,30,37,38,39,40,41,42,26,43,44,45,46],"Vein Stent","VIAFORT","Venous Thrombosis","Gore","Venous occlusion","VIABAHN FORTEGRA","FORTEGRA","Deep Venous Insufficiency","Deep venous","DVT Treatment","Venous Stent","Venous insufficiency treatment options","Venous disease treatment options","NOT_YET_RECRUITING","2026-08-11",{"date":50,"type":51},"2026-08-12","ACTUAL",{"date":53,"type":19},"2026-10-07",{"date":55,"type":19},"2031-05",{"name":57,"class":58},"W.L.Gore & Associates","INDUSTRY",{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":4,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":66,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":86},"100578115","wrap-north-america-100578115","NCT06807099","WRAP North America","Prospective, Multicenter, Observational Study to Evaluate the Merit WRAPSODY® Cell Impermeable Endoprosthesis for Treatment of Stenosis or Occlusion Within the Dialysis Outflow Circuit (WRAP North America)","Inclusion Criteria:\n\n1. Subject provides written informed consent for study participation.\n2. Subject is male or female, with an age ≥ 18 years at date of enrollment.\n3. Subject is willing to comply with site standard of care procedures and follow-up visit schedules over 36 months.\n4. Subject is undergoing chronic hemodialysis with the hemodialysis access the intervention will be performed upon.\n5. The dialysis access is considered mature and has been used to deliver hemodialysis treatments for at least one session.\n6. Subject has stenosis or occlusion within the dialysis outflow circuit and is treated with WRAPSODY CIE in accordance with device instructions for use.\n\nExclusion Criteria:\n\n1. Subject has a planned surgical revision of access site.\n2. Subject has a known or suspected infection of the hemodialysis access site, systemic infection and\u002For septicemia.\n3. Subject has an uncorrectable coagulation disorder.\n4. Known hypersensitivity to nickel or titanium.\n5. Subject's hemodialysis access is anticipated to be abandoned within 6 months.\n6. Subject is scheduled for kidney transplant or peritoneal dialysis within the next 6 months post-procedure.\n7. Full expansion of a PTA balloon cannot be achieved during predilatation.\n8. Device would be placed in the Superior Vena Cava\n9. Any inflow or outflow lesion that could jeopardize patency access long-term beyond the target treatment area.",{"count":67,"type":19},250,"OBSERVATIONAL","The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population. Participants treated with the WRAPSODY CIE device in accordance with the device instructions for use will be followed in accordance with standard of care up to 3-years post-procedure.",[30,31],[72,73,74,75],"Arteriovenous Fistula (AVF)","Arteriovenous Graft (AVG)","AV fistula","AV graft","RECRUITING","2026-06-16",{"date":79,"type":51},"2026-06-17",{"date":81,"type":51},"2025-07-31",{"date":83,"type":19},"2030-07",{"name":85,"class":58},"Merit Medical Systems, Inc.",16,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":20,"phases":97,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":76,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100523473","the-solaris-de-endoprosthesis-for-the-treatment-of-av-access-stenosis-or-occlusion-100523473","NCT06096142","The Solaris DE Endoprosthesis for the Treatment of AV Access Stenosis or Occlusion","Prospective, Randomized, Controlled, Multicenter Study of the Solaris DE Endoprosthesis in the Treatment of Venous Outflow Stenosis or Occlusion in Hemodialysis Patients","DEScover","Inclusion Criteria:\n\n* The participant has a mature AV Fistula (AVF) or Graft (AVG) in the arm created ≥ 30 days before the initial procedure and is in use for dialysis therapy\n* The participant has clinical and\u002For hemodynamic evidence of a venous outflow obstruction or AV fistula or graft dysfunction. The stenotic lesion is ≥ 50%, with a maximum length of 8 cm and a distal reference vessel diameter from 4.0 mm to 9.0 mm\n* The participan provides written informed consent prior to any study-specific procedure\n* The participan is willing to undergo all follow-up evaluations according to the specified schedule over 24 months\n\nAngiographic Inclusion Criteria:\n\n* The target lesion originates ≥ 3 cm from the cannulation segment (needling zone)\n* The target lesion is located:\n\n  1. In one arm (including the cephalic arch) in a participant with AVF, and not in the cannulation segment, OR\n  2. In the anastomosis or juxta-anastomosis in a participant with AVF (a juxta-anastomosis is defined as a location where the stent crosses the venous anastomosis)\n* The target lesion includes a de novo stenotic lesion or restenosis\n* The target lesion is ≥ 5 cm from the arterial anastomosis\n* The target lesion has ≥ 50% stenosis according to the operator's visual judgment\n* The distal reference vessel diameter of the target lesion is between 4.0 mm and 9.0 mm by the operator's visual judgment\n* Single or multiple target lesions measuring ≤ 8 cm in total length by the operator's visual judgment\n* Single or multiple target lesions should be covered by a single stent or multiple overlapping stents, provided they are treated as a single lesion with a maximum length of 8 cm\n* Successful target lesion pre-dilatation is defined as crossover of the guidewir resulting in full expansion of the pre-dilatation balloon\n* The participant has up to 1 (one) non-target lesion in the access circuit requiring intervention in the initial procedure. The non-target lesion must be at least 10 cm away from the target lesion. The non-target lesion can only be treated with standard PTA alone\n* Does not have stent implanted or it has been in the access circuit for ≥ 30 days since placement and patent with ≤ 30% stenosis and located ≥ 5 cm from the target lesion\n* The non-target lesion must be successfully treated at the time of the initial procedure (success measured as ≤30% residual stenosis and no complications).\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding or with intention to become pregnant in the next year\n* The participant has any major endovascular or surgical procedure planned (including in the access circuit) within 30 days of the initial procedure\n* It was not possible to pre-dilate the lesion to be treated with Solaris DE\n* Planned surgical revision of the access site\n* Known or suspected infection of the hemodialysis access site, systemic infection and\u002For sepsis\n* Patients on immunosuppressive therapy\n* Known active coagulopathy or bleeding diathesis\n* Known hypersensitivity to nickel titanium alloy, contrast or sirolimus\n* Contraindication to antiplatelet, anticoagulant or thrombolytic therapies\n* Known allergy to contrast agents or medications administered to perform endovascular intervention that cannot be adequately premedicated\n* Life expectancy of less than 12 months\n* Has a stent or endoprosthesis located anywhere in the AV access circuit that is not patent (\\> 30% stenosis) or implanted \\\u003C 30 days\n* The participant's hemodialysis access is expected to be abandoned within 6 months\n* The participantis is enrolled in another trial involving an investigational product (pharmaceutical, biological or medical device)\n* The patient has a permanent central venous catheter (CVC) for dialysis access, except when its use is temporary, as a bridge to treatment through the access circuit, with a plan for removal after a successful dialysis session after the initial procedure\n\nAngiographic Exclusion Criteria:\n\n* The target lesion is located inside an endoprosthesis\n* Target lesion treatment would involve the cannulation segment (needling zone)\n* The target lesion is \\\u003C 5 cm from the arterial anastomosis\n* There was a dissection or rupture of the treated vessel during the initial treatment that could not be controlled\n* Evidence of an aneurysm, pseudoaneurysm or acute thrombus (i.e. one that has been treated ≤ 15 days) within the target lesion\n* The target lesion is, and\u002For Solaris DE would be placed anywhere:\n\n  1. Through the elbow\n  2. In a region that causes bending of the endoprosthesis or bony protrusion over it\n  3. In the cannulation segment (needling zone)\n  4. Inside any part of a pre-existing stent or endoprosthesis (apart from an access arteriovenous graft)\n  5. Lower extremity\n  6. Non-synthetic graft\n  7. Central thoracic veins located proximal to the cephalic vein arch\n* The target lesion is located in such a way that the insertion of a stent would result in a \"kink\" area that requires a stent bridge between the Solaris DE and an existing stent or stent graft\n* The individual has more than 1 (one) non-target lesion (≥ 50% stenosis) that requires intervention in the initial procedure",{"count":96,"type":19},120,[22],"The goal of this clinical trial is to demonstrate the safety and efficacy of Solaris DE Endoprosthesis in the treatment of stenosis or occlusion within the outflow circuit of the dialysis access including arteriovenous (AV) fistula and synthetic AV graft.\n\nParticipants will be treated with Solaris DE Endoprosthesis. Researchers will compare the treatment with investigational product to Percutaneous Transluminal Angioplasty (PTA) alone within the AV fistula cohort in order to demonstrate superiority of Solaris DE.",[30,31,100],"Chronic Renal Failure","2026-03-13",{"date":103,"type":51},"2026-03-17",{"date":105,"type":51},"2024-08-30",{"date":107,"type":19},"2028-02",{"name":109,"class":58},"Scitech Produtos Medicos SA",5]