[{"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":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,87,112],{"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":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100578115","wrap-north-america-100578115",false,"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.","ALL","18 Years",{"count":19,"type":20},250,"ESTIMATED","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.",[24,25],"Venous Stenosis","Venous Occlusion",[27,28,29,30],"Arteriovenous Fistula (AVF)","Arteriovenous Graft (AVG)","AV fistula","AV graft","RECRUITING","2026-06-16",{"date":34,"type":35},"2026-06-17","ACTUAL",{"date":37,"type":35},"2025-07-31",{"date":39,"type":20},"2030-07",{"name":41,"class":42},"Merit Medical Systems, Inc.","INDUSTRY",16,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":63,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":4},"100634355","the-gore-viabahn-fortegra-venous-stent-post-approval-study-100634355","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.",{"count":51,"type":20},150,"INTERVENTIONAL",[54],"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.",[57,58,59,60,61,24,25,62],"Venous Thromboses","Venous Disease","Venous Leg Ulcer","Venous Stasis","Venous Ulcer","Vein Thrombosis",[64,65,66,24,67,68,69,70,71,72,58,73,74,75,76],"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","2026-05-11",{"date":80,"type":35},"2026-05-14",{"date":82,"type":20},"2026-10-07",{"date":84,"type":20},"2031-05",{"name":86,"class":42},"W.L.Gore & Associates",{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":52,"phases":96,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100476872","the-gore-viabahn-fortegra-venous-stent-iliofemoral-study-100476872","NCT05489588","The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study","Evaluation of the GORE® VIAFORT Vascular Stent for Treatment of Symptomatic Iliofemoral Venous Obstruction","Preoperative Inclusion Criteria:\n\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.\n* One of the following: Clinical severity class of CEAP 'C' classification ≥3 or rVCSS pain score ≥2.\n* Intention to treat the target areas with only the GORE® VIAFORT Vascular Stent.\n* Estimated life expectancy ≥1 year.\n* Patient is ambulatory (use of assistive walking device such as a cane or walker is acceptable).\n* Patient has adequate inflow to the target lesion(s), per investigator\u002Fsub-investigator discretion, involving at least a patent femoral or deep femoral vein.\n* Presence of non-malignant symptomatic unilateral iliofemoral venous obstruction.\n\nPreoperative Exclusion Criteria:\n\n* Patient has DVT in the target areas with symptom onset date greater than 14 days but less than or equal to 90 days prior to treatment.\n* Patient is a pregnant or breastfeeding woman, or a woman planning to become pregnant through the 12-month visit.\n* Patient has clinically significant (e.g., symptoms of chest pain, hemoptysis, dyspnea, hypoxia, etc.) pulmonary embolism (confirmed via Computed Tomography Angiography) at the time of enrollment.\n* Patient has a known uncorrectable bleeding diathesis or active coagulopathy meeting the following definitions (all must be tested for):\n\n  1. uncorrected INR\\>2 (not as a result of warfarin or DOAC therapy), OR\n  2. platelet count \\\u003C50,000 or \\>1,000,000 cells\u002Fmm3, OR\n  3. white blood cell count \\\u003C3,000 or \\>12,500 cells\u002Fmm3\n* Patient has impaired renal function (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m2) or is currently on dialysis.\n* Patient has uncorrected hemoglobin of \\\u003C9 g\u002FdL.\n* Patient has known history of antiphospholipid syndrome (APS).\n* Patient has known homozygous or acquired coagulation defect (e.g., Protein C or Protein S deficiency) that cannot be treated with therapeutic anticoagulation.\n* Patient has a planned surgical intervention that has the potential to clinically interfere with the endpoints of this treatment (other than pre-stenting procedures such as thrombolysis or thrombectomy) within 30 days prior to or within 30 days after the planned study procedure. Examples include surgical interventions that may impact mobility, and surgical interventions that require cessation of therapeutic antiplatelet or anticoagulation within 30 days following the index procedure.\n* Patient has had or requires open deep venous surgery in the target limb.\n* Patient is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this treatment, in the opinion of the investigator\u002Fsub-investigator. Observational studies are permitted.\n* Patient has had a previous major (i.e., above the ankle) amputation of the target lower limb.\n* Patient has known sensitivity to device materials.\n* Patient has had prior stenting or grafts in the target vessels.\n* Patient has a known or suspected active systemic infection at the time of the index procedure. Patients with a chronic infection (e.g., HIV, hepatitis C) that can be managed, and with an active clinical plan in place may be eligible.\n* Patient has known history of intravenous drug abuse within one year of treatment.\n* Patient has significant peripheral arterial disease (chronic Rutherford Type 2 or greater, acute Rutherford Type IIa or greater).\n* Patient has a BMI \\>45. Patients with a BMI of up to 45 may be enrolled provided that diagnostic quality ultrasound of the implant sites can be performed.\n* Patient is actively undergoing or plans to begin cancer treatment.\n* Patients with hypercoagulable states that are unwilling to take anticoagulant medications on a long-term basis.\n* Patient has contraindication to thrombolytics, anticoagulants, or iodinated contrast necessary for the index procedure and long-term medical therapy (contrast pre-medication is acceptable).\n\nIntraoperative Inclusion Criteria:\n\n* Presence of non-malignant unilateral obstruction of the common femoral vein, external iliac vein, and\u002For common iliac vein defined as occlusion or at least 50% reduction in target vessel lumen as measured by procedural IVUS and venogram.\n* Patient can accommodate an appropriately sized GORE® VIAFORT Vascular 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 within the native vessels beyond the proximal and distal margins of the lesion.\n* Patient has adequate inflow to the target lesion(s), per investigator\u002Fsub-investigator discretion, involving at least a patent femoral or deep femoral vein.\n* Lesion can be traversed with a guidewire.\n* Disease involves only unilateral iliofemoral venous segments with intent to stent all affected iliofemoral segments. Patients with disease extending into the inferior vena cava or contra-lateral iliofemoral veins who are anticipated to require endovascular or surgical treatment within 12 months after investigational device implant will be excluded.\n* Patient does not have significant (i.e., \\>20% residual thrombosis) acute thrombus within the target stent area at the time of investigational device placement. Patients with acute thrombus within the target stent area must have thrombus successfully treated prior to investigational device placement. Successful thrombus treatment is defined as reestablishment of antegrade flow with ≤20% residual thrombosis as confirmed by IVUS and venogram, AND freedom from bleeding, vascular injury, or hemodynamically significant pulmonary embolism. After successful thrombus treatment, investigational device placement can occur within the same procedure.",{"count":95,"type":20},165,[54],"This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.",[57,58,59,60,61,24,25,62,99,100],"Vein Occlusion","Vein Disease",[65,64,66,24,67,25,70,69,58,71,102,72,73,74,75],"Venous disease treatment Options","2026-04-07",{"date":105,"type":35},"2026-04-09",{"date":107,"type":35},"2023-03-02",{"date":109,"type":20},"2031-03",{"name":86,"class":42},27,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":52,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":135},"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":121,"type":20},120,[54],"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.",[24,25,125],"Chronic Renal Failure","2026-03-13",{"date":128,"type":35},"2026-03-17",{"date":130,"type":35},"2024-08-30",{"date":132,"type":20},"2028-02",{"name":134,"class":42},"Scitech Produtos Medicos SA",5]