[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"W.L.Gore & Associates\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":629},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,43,84,126,153,184,203,244,263,286,314,337,362,396,425,444,470,497,522,546,577,604],{"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":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100605716","gore-tag-thoracic-branch-endoprosthesis-zone-01-post-approval-study-100605716",false,"NCT07166133","GORE® TAG® Thoracic Branch Endoprosthesis Zone 0\u002F1 Post-Approval Study","Inclusion Criteria:\n\n1. Patient or legally authorized representative (LAR) provides written authorization and\u002For consent per institution and geographical requirements.\n2. Patient has been or is intended to be treated with the TBE Device in Zone 0 or Zone 1.\n3. Patient is age ≥ 18 years at time of informed consent signature.\n\nExclusion Criteria:\n\n1. Patient who is, at the time of consent, unlikely to be available for defined follow-up visits.\n2. Patient with exclusion criteria required by local law.\n3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and\u002For investigational device study within 12 months of study enrollment. Subjects cannot be enrolled in another Gore study.","ALL","18 Years",{"count":18,"type":19},125,"ESTIMATED","INTERVENTIONAL",[22],"NA","A prospective multi-center post-market study collecting outcomes through at least 5-years and up to 10-years post procedure for subjects treated with the TBE Device in Zone 0\u002F1 as part of routine clinical practice.",[25,26],"Aortic Arch Dissection","Aortic Arch Aneurysm",[28,29],"Zone 0","Zone 1","RECRUITING","2026-06-19",{"date":33,"type":34},"2026-06-23","ACTUAL",{"date":36,"type":34},"2026-03-02",{"date":38,"type":19},"2036-03",{"name":40,"class":41},"W.L.Gore & Associates","INDUSTRY",7,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":64,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100566711","long-term-characterization-of-gore-tag-conformable-thoracic-stent-graft-with-active-control-system-performance-100566711","NCT06658730","Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance","TGR 23-02TA","Inclusion Criteria:\n\n1. Patient or legally authorized representative (LAR) provides written authorization and\u002For consent per institution and geographical requirements.\n2. Patient has been or is intended to be treated with an eligible registry device.\\*\n3. Patient is age ≥ 18 years at time of informed consent signature.\n\n   * The intent to treat a patient with a Gore product must be made prior to soliciting for possible registry participation. If pre-procedure consent is not feasible due to emergent situation, consent prior to the time of discharge for the index procedure is acceptable.\n\nExclusion Criteria:\n\n1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.\n2. Patient with exclusion criteria required by local law.\n3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and\u002For investigational device study\\* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.\n\n   * The term \"study\" does not apply to other observational registries or quality improvement projects. Collection of Registry Device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions).",{"count":51,"type":19},1500,"10 Years","OBSERVATIONAL","An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w\u002FAC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.",[56,57,58,59,60,61,62,63],"Vascular Disease","Dissection","Dissection Aortic Aneurysm","Dissection of Aorta","Aneurysm Thoracic","Aneurysm Dissecting","Transection Aorta","Intramural Hematoma",[65,66,67,68,69,70,71,72,73,74,48,75,76],"Endovascular","CTAG","Post-market Registry","Observational","Multi-regional","Real world data","Together Registry","Gore Together Registry","Gore Together Aortic Registry","Conformable Thoracic Stent Graft","TGR23-02TA","GORE TAG",{"date":33,"type":34},{"date":79,"type":34},"2025-06-19",{"date":81,"type":19},"2038-08",{"name":40,"class":41},36,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":90,"targetDuration":92,"studyType":53,"phases":4,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"100614442","gore-viabahn-vbx-balloon-expandable-endoprosthesis-post-market-clinical-follow-up-pmcf-observational-registry-re-prove-100614442","NCT07279649","GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Post-Market Clinical Follow-Up (PMCF) Observational Registry (RE-PROVE)","Inclusion Criteria:\n\n1. Age ≥18 years\n2. Informed Consent Form (ICF) is signed by subject\n3. Suitable for endovascular treatment with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) device\n4. Willingness of the subject to adhere to institutional standard of care follow-up requirements\n\nExclusion Criteria:\n\n1. Previous or concurrent enrollment into this registry (e.g., previous enrollment into another treatment cohort or subject requires enrollment into more than one cohort) (Note: Only the first treatment will be enrolled if concurrent procedures are performed that would require enrollment into more than one cohort).\n2. Participation in concurrent research study or registry which may confound registry results, unless approved by Gore.\n3. Known hypersensitivity to heparin, including a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.\n4. Life expectancy \\\u003C12 months due to comorbidities or unlikely to be available for standard of care follow-up visits as defined by sites.\n5. Known intolerance to anticoagulant and \u002F or antiplatelet therapy at the time of the index procedure\n6. Subject has a known allergy to contrast or the Reduced Profile VBX Stent (BXB) device components at the time of index procedure that cannot be adequately mitigated.\n7. Pregnant or breast-feeding subject at time of informed consent signature.\n8. Subject has other medical conditions which, as determined by the investigator, may confound the data interpretation (e.g., sepsis, thrombophilic diseases, connective tissue disorders).",{"count":91,"type":19},240,"12 Months","Collect real-world post-market clinical follow-up data on subjects treated with the Reduced Profile GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (Reduced Profile VBX Stent Graft-BXB)",[95,96,97,98],"Aorto-iliac Occlusive Disease (AIOD)","Visceral Artery Occlusive Disease (VAOD)","Isolated Artery Aneurysms (IAA)","Trauma or Iatrogenic Vessel Injury",[100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116],"Peripheral Vascular Disease","Peripheral Arterial Disease","Aneurysm","Cardiovascular Disease","Trauma","Injury","Iliac","BXB","Aortoiliac occlusive disease","Visceral artery occlusive disease","Iliac arteries","visceral arteries","subclavian artery aneurysms","iatrogenic vessel injuries","FEVAR","BEVAR","CERAB","2026-05-29",{"date":119,"type":34},"2026-06-02",{"date":121,"type":34},"2026-05-08",{"date":123,"type":19},"2031-01",{"name":40,"class":41},1,{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":20,"phases":135,"briefSummary":136,"conditions":137,"keywords":142,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":4},"100636337","mba-early-feasibility-study-100636337","NCT07564375","MBA Early Feasibility Study","Early Feasibility Study of the GORE® Multibranch Arch Endoprosthesis (MBA Device)","Inclusion Criteria:\n\nThe subject is \u002F has:\n\n1. Thoracic pathologies with involvement of the arch branch vessels, that are compatible with the treatment requirements of the MBA device, and meeting any of the following criteria:\n\n   a) Aneurysm and Isolated Lesions: i. Fusiform aneurysm (≥ 55 mm or documented growth rate \\> 0.5 cm\u002Fyear). ii. Saccular aneurysm (no diameter criteria). iii. Pseudoaneurysms (\\> 30 days post-surgery, no diameter criteria). iv. Penetrating Aortic Ulcers (PAUs) without intramural hematoma (IMH) (no diameter criteria).\n\n   b) Aortic dissection: i. Uncomplicated and high-risk chronic de novo (\\> 90 days) Type B aortic dissection with primary entry tear in the arch or descending thoracic aorta.\n\n   ii. Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (\\> 30 days post-treatment).\n\n   iii. Proximal extension of prior endovascular repair (\\> 30 days post-treatment and \\> 90 days post-dissection) of a Type B dissection requiring treatment.\n\n   iv. Pseudoaneurysms, following open surgical repair of a Type A dissection (\\> 30 days post-surgery, no diameter criteria).\n2. Anatomic compatibility with MBA device and other devices required for proximal or distal extensions based on Gore's review.\n\n   1. Adequate vascular access via transfemoral or retroperitoneal approach.\n   2. Appropriate vascular access to allow for through-wire access to the brachiocephalic artery, LCCA, and LSA.\n   3. Proximal Aortic Landing Zone:\n\n   i. Landing zone is native aorta, surgical graft, or previously implanted GORE thoracic stent graft.\n\nii. Landing zone diameter between 27 mm - 48 mm. iii. Acceptable ascending aorta outer curvature length for the required MBA device.\n\n1. Proximal segment length (length from distal edge of brachiocephalic artery to distal edge of the most distal coronary artery) must be ≥ 2 cm longer than the \"AC Proximal End to BCA Portal Length\" for the selected Aortic Component or ≥ 3 cm if the landing zone is \\> 42 mm.\n2. For patients with patent bypass graft from the ascending aorta, proximal extent of landing zone must be ≥ 1 cm distal to the bypass graft.\n\niv. Lesion location is ≥ 2 cm distal to the most distal coronary artery ostium. v. For patients with an existing transcatheter aortic valve replacement (TAVR) there must be a sufficient proximal landing zone to avoid interference with the required MBA device (including any proximal extensions with the ASG device).\n\nvi. Proximal landing zone must be ≥ 2 cm in the ascending aorta.\n\n1. For patients with prior replacement of the ascending aorta and \u002F or aortic arch by surgical graft, there must be ≥ 2 cm overlap of MBA device and previously implanted graft.\n2. For patients with a de novo aortic dissection, the primary entry tear must be located ≥ 2 cm distal to the proximal extent of the MBA device (including any proximal extensions) and the proximal edge of the stent graft must land in non-dissected aorta.\n\n   vii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed.\n\n   d) Branch Vessel Landing Zone: i. Length of ≥ 2.5 cm proximal to first major branch vessel. ii. Target branch vessel inner diameter of 11-18 mm for the 12 mm portal, and 6-15 mm for the 8 mm portal.\n\n   iii. Target branch vessel landing zone must be in native aorta that cannot be heavily calcified, or heavily thrombosed.\n\n   iv. All three arch target vessels must have appropriate anatomy for cannulation (including through-wire access) and treatment with MBA branch components.\n\n   e) Distal Aortic Landing Zone (aneurysms and isolated lesions only): i. Outer curvature length must be ≥ 2 cm proximal to the celiac artery. ii. Aortic inner diameters between 16-42 mm. iii. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed.\n\n   iv. Landing zone in native aorta, surgical graft, or previously implanted GORE thoracic stent graft.\n3. Age ≥ 18 years at time of informed consent signature.\n4. Informed Consent Form (ICF) signed by the subject or legally authorized representative (LAR), according to local regulation.\n5. Agrees to comply with protocol requirements, including imaging and five year (60 month) follow-up.\n6. Considered high-risk for open surgical repair by meeting one or more of the following criteria:\n\n   1. ≥ 75 years of age\n   2. Previous median sternotomy\n   3. Documented identification of other subject-specific risk factors (e.g., medical history, active medical diagnosis) by a study investigator and an experienced open ascending and \u002F or aortic arch surgeon (e.g., cardiothoracic surgeon).\n7. Considered high-risk for surgical debranching by meeting one or more of the following criteria:\n\n   1. Prior neck surgery or radiation\n   2. Neck anatomy \u002F body habitus impeding carotid access or safe bypass tunneling\n   3. Dysphagia\n   4. Elevated risk for post-operative infection (e.g., malnutrition, uncontrolled diabetes (hemoglobin A1c \\> 9%), current treatment with immunosuppressant therapy or chemotherapy)\n   5. Reduced pulmonary function (e.g., severe chronic obstructive pulmonary disease (COPD), current or anticipated tracheostomy)\n   6. Clinical Frailty Scale score 6-7\n   7. Documented identification of other subject-specific risk factors which would pose high risk for surgical debranching (e.g., medical history, active medical diagnosis) by a study investigator\n\nExclusion Criteria:\n\nThe subject is \u002F has:\n\n1. De novo Type A dissection\n2. Requires immediate treatment.\n3. Arch vessels with dissection extending into the intended landing zones.\n4. Anticipated need for coronary or aortic valve intervention within one year post-treatment.\n5. Any aortic valve repair or replacement including transcatheter aortic valve replacement (TAVR) or coronary artery intervention within 30 days prior to treatment.\n6. Complex percutaneous coronary intervention (PCI) within 30 days prior to treatment.\n7. Open chest surgical repair within 30 days prior to treatment.\n8. Any open or interventional repair of either carotid artery within 30 days prior to treatment.\n9. Presence of Intramural Hematoma (IMH) in landing zones.\n10. Prosthetic heart valve in the aortic position that precludes safe delivery of any study device.\n11. Aortic insufficiency (AI) grade 3 or greater.\n12. Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair.\n13. Concomitant vascular disease, including disease associated with the great and upper extremity vessels, requiring treatment that is not planned for index endovascular procedure.\n14. Any stroke or MI within 90 days prior to treatment.\n15. Presence of protruding and \u002F or irregular thrombus and \u002F or atheroma in the ascending aorta or aortic arch or any other factor that could increase the risk of stroke based on Gore's review.\n16. Any chronic condition that is not well controlled and that is known to increase stroke risk.\n17. Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome (EDS)).\n18. Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor.\n19. Known medical, social, or psychological issues that the Investigator believes may interfere with treatment or follow-up, such as a history of drug abuse within one year of treatment.\n20. Pregnant at time of procedure or planning to become pregnant within the first 12-months of participation in the study.\n21. Active infected aorta, mycotic aneurysm.\n22. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).\n23. Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 (mL\u002Fmin\u002F1.73 m2) or currently requiring dialysis.\n24. Life expectancy \\\u003C12 months.\n25. Known sensitivities or allergies to the device materials.\n26. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.\n27. Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta.\n28. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin or a history of a hypercoagulability disorder and \u002F or state.\n29. Severe Congestive Heart Failure (CHF) (New York Heart Association (NYHA) functional class IV).\n30. Acute Coronary Syndrome (ACS) including unstable angina.",{"count":134,"type":19},20,[22],"The MBA 25-04 study is a prospective, multicenter, non-randomized, single-arm, early feasibility study designed to assess the initial safety of the MBA device through five years following the index endovascular procedure.",[138,139,140,141],"Thoracic Aortic Aneurysm","Penetrating Aortic Ulcers (PAUs)","Thoracic Aortic Dissection","Pseudoaneurysm",[143],"MBA 25-04","NOT_YET_RECRUITING","2026-05-27",{"date":147,"type":34},"2026-06-01",{"date":149,"type":19},"2026-09",{"date":151,"type":19},"2034-11",{"name":40,"class":41},{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":161,"targetDuration":163,"studyType":53,"phases":4,"briefSummary":164,"conditions":165,"keywords":172,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":4},"100629878","real-world-data-collection-of-gore-devices-used-in-the-endovascular-treatment-of-aortic-aneurysms-which-incorporate-visceral-arteries-100629878","NCT07480395","Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.","The ENVISION Registry: REal-World Data CollectioN of GORE deVIceS Used In the endOvascular treatmeNt of Aortic Aneurysms Which Incorporate Visceral Arteries.","ENVISION","Inclusion Criteria:\n\n1. Informed Consent Form (ICF) is signed by Subject.\n2. Age ≥ 18 years at time of informed consent signature.\n3. Patient presents with thoracoabdominal, pararenal, juxtarenal, or short-neck infrarenal aortic pathology suitable for endovascular repair.\n4. Patient requires the incorporation of ≥ 1 visceral artery and is suitable for use of at least 1 GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (BXB) as a bridging stent (Note: Up to six (6) visceral arteries may be incorporated).\n5. Patient is willing to adhere to the institutional standard of care follow-up.\n\nExclusion Criteria:\n\n1. Patient has a prior visceral artery stenting not associated with registry procedure.\n2. Patient treated for acute or sub-acute dissection, \\\u003C90 days from onset of symptoms\n3. Patient is intended to be treated with a parallel grafting (e.g., chimney, periscope, sandwich) or octopus technique.\n4. Known hypersensitivity to heparin or a previous incident of Heparin-Induced Thrombocytopenia (HIT) type II.\n5. Patient has known coagulation disorders including hypercoagulability that are not amenable to treatment.\n6. Patient has a life expectancy \\\u003C 1-year.\n7. Patient is participating in an investigational study which may confound registry results, unless approved by Gore",{"count":162,"type":19},400,"5 Years","The registry population consists of patients presenting with complex aortic pathologies amenable to endovascular aortic repair that requires the incorporation of bridging stents to maintain visceral artery perfusion",[166,167,168,169,170,171],"Complex Aortic Aneurysms","Thoracoabdominal Aneurysm","Fenestrated Endovascular Aortic Repair","Endovascular Aortic Repair","Abdominal Aorta Aneurism","Chronic Dissection",[114,115,173,174,175,176,177],"TAAA","AAA","Visceral","aortic aneurysm","PMEGs",{"date":147,"type":34},{"date":180,"type":19},"2026-12",{"date":182,"type":19},"2035-12",{"name":40,"class":41},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":190,"enrollmentInfo":191,"targetDuration":4,"studyType":53,"phases":4,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":202},"100583175","real-world-data-collection-of-the-gore-viabahn-vbx-balloon-expandable-endoprosthesis-when-used-in-covered-endovascular-reconstruction-of-the-aortic-bifurcation-cerab-to-treat-aortoiliac-occlusive-disease-100583175","NCT06872905","Real-World Data Collection of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis When Used in Covered Endovascular Reconstruction of the Aortic Bifurcation (CERAB) to Treat Aortoiliac Occlusive Disease","Inclusion Criteria:\n\n1. Patient treated with covered endovascular reconstruction of the aortic bifurcation (CERAB) procedure for aortoiliac occlusive disease (AIOD).\n2. Patient was implanted with the VBX Device in the aortic position during a CERAB procedure.\n3. Patient was treated with the CERAB procedure a minimum of 1 year before enrollment date.\n4. Age ≥18 years at the time of CERAB procedure.\n5. Obtain patient informed consent or waiver according to local Institutional Review Board (IRB)\u002FEthics Committee (EC) -\n\nExclusion Criteria:\n\n1. Patient with prior stenting in the aortic or common iliac artery at the time of CERAB procedure.\n2. Patient treated with concomitant chimney procedure at time of CERAB procedure (e.g., inferior mesenteric artery, renal artery).\n3. Participation in another drug or device investigational study at the time of the CERAB procedure date that can confound the study endpoints.\n\n   \\-","100 Years",{"count":192,"type":19},158,"The study will assess the safety and effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (\"VBX Device\" or also referred to as \"VBX Stent Graft\") in a post approval setting and evaluate the quality of the use in covered endovascular reconstruction of the aortic bifurcation (CERAB) to treat Aortoiliac Occlusive Disease (AIOD).",[195],"Aortoiliac Occlusive Disease",{"date":117,"type":34},{"date":198,"type":34},"2025-05-30",{"date":200,"type":19},"2027-08-16",{"name":40,"class":41},25,{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":20,"phases":211,"briefSummary":212,"conditions":213,"keywords":222,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":237,"startDateStruct":239,"completionDateStruct":241,"leadSponsor":243,"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":210,"type":19},150,[22],"This study is a prospective, multicenter, single-arm post-market clinical study to evaluate the GORE® VIABAHN® FORTEGRA Venous Stent in real-world use.",[214,215,216,217,218,219,220,221],"Venous Thromboses","Venous Disease","Venous Leg Ulcer","Venous Stasis","Venous Ulcer","Venous Stenosis","Venous Occlusion","Vein Thrombosis",[223,224,225,219,226,227,228,229,230,231,215,232,233,234,235],"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","2026-05-11",{"date":238,"type":34},"2026-05-14",{"date":240,"type":19},"2026-10-07",{"date":242,"type":19},"2031-05",{"name":40,"class":41},{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":20,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":236,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":262},"100501600","the-gore-vbx-forward-clinical-study-a-comparison-of-the-gore-viabahn-vbx-balloon-expandable-endoprosthesis-to-bare-metal-stenting-for-patients-with-complex-iliac-occlusive-disease-100501600","NCT05811364","The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease","Inclusion Criteria:\n\n* Age ≥ 18 years at time of informed consent signature\n* Informed Consent Form (ICF) is signed by the subject\n* Subject can comply with protocol requirements, including follow-up\n* Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)\n* Patient has de novo or restenotic lesion(s) found in the common and\u002For external iliac artery(ies)\n* Patient has: Unilateral or bilateral single or multiple lesions (\\>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length\n* Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm\n* Patient has a sufficient (\\\u003C50% stenotic) common femoral artery and at least one sufficient (\\\u003C50% stenotic) femoral artery (deep or superficial).\n* Patient has at least one sufficient (\\\u003C50% stenotic) infrapopliteal run-off vessel.\n\nExclusion Criteria:\n\n* Life expectancy \\\u003C1 year\n* Patient is pregnant at time of informed consent.\n* Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).\n* Patient has severe chronic renal insufficiency (serum creatinine level \\> 2.5mg\u002FdL) and not undergoing hemodialysis.\n* Patient has evidence of a systemic infection.\n* Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.\n* Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).\n* Patient has previous stenting in the iliac arteries.\n* Patient has previous surgical bypass in the target limb.\n* Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.\n* Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery.\n* Patient has an abdominal aortic artery lesion or aneurysm.\n* Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.\n* Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extend into the external iliac artery).\n* Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral \u002F tibial revascularization).",{"count":251,"type":19},244,[22],"The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.",[195,101],{"date":256,"type":34},"2026-05-13",{"date":258,"type":34},"2023-10-17",{"date":260,"type":19},"2032-01-31",{"name":40,"class":41},43,{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":270,"targetDuration":272,"studyType":53,"phases":4,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":277,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":285},"100604288","tambe-japan-post-marketing-surveillance-100604288","NCT07147569","TAMBE Japan Post-Marketing Surveillance","GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis Post-Marketing Surveillance","Inclusion Criteria:\n\n* Patients who were attempted to implant the AC\n* Thoracoabdominal aortic aneurysm\n* Pararenal abdominal aortic aneurysm\n\nExclusion Criteria:\n\n* N\u002FA",{"count":271,"type":19},100,"60 Months","To evaluate the safety and efficacy of multi component system (TAMBE device) including GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (Aortic Component; AC) under post-marketing use.",[275,276],"Thoracoabdominal Aortic Aneurysm","Pararenal Aortic Aneurysm","2026-05-04",{"date":279,"type":34},"2026-05-05",{"date":281,"type":34},"2026-03-27",{"date":283,"type":19},"2034-02-28",{"name":40,"class":41},5,{"id":287,"slug":288,"hasResults":11,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":293,"enrollmentInfo":294,"targetDuration":4,"studyType":20,"phases":296,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},"100348771","gore-cardioform-septal-occluder-and-antiplatelet-medical-management-for-reduction-of-recurrent-stroke-in-patients-with-patent-foramen-ovale-pfo-the-reduce-post-approval-study-100348771","NCT03821129","GORE® CARDIOFORM Septal Occluder and Antiplatelet Medical Management for Reduction of Recurrent Stroke in Patients With Patent Foramen Ovale (PFO): the REDUCE Post Approval Study","REDUCE PAS","Inclusion Criteria:\n\n* Diagnosed with an ischemic stroke presumed to be an embolic stroke of undetermined source (ESUS) verified by a neurologist within the last 365 days prior to enrollment.\n* Presence of Patent Foramen Ovale (PFO), as determined initially by positive bubble study utilizing transesophageal echocardiography (TEE) and\u002For transcranial Doppler (TCD), demonstrating spontaneous right-to-left shunting or right-to-left shunting during Valsalva maneuver.\n* Patient is able to tolerate antiplatelet therapy\n* Note: Additional Inclusion Criteria may apply\n\nExclusion Criteria:\n\n* History of or ongoing atrial fibrillation\u002Fflutter\n* Other co-morbidities including, but not limited to, mural thrombus, dilated cardiomyopathy, cardiac prosthetics (valves), severe native valve disease (including mitral valve stenosis), severe ventricular wall motion abnormalities, aortic dissection, significant atherosclerosis, vasculitis, pre-existing non-vascular neurologic disorders, pulmonary arteriovenous malformations, prior intracranial hemorrhage, severe disability related to prior stroke, autoimmune disorders that would increase the risk of stroke or thromboembolism, or associated with increased risk of infection or procedural complications, in the opinion of the investigator, left ventricular ejection fraction of \\\u003C40%, coexistent cause or intra-cardiac shunting (e.g. VSD or ASD)\n* Previous Myocardial Infarction\n* Rankin Scale sore greater than or equal to 3 at the time of procedure\n* Active infection that cannot be treated successfully prior to enrollment\n* Neurological deficits not due to stroke that may affect the patient's neurologic assessments\n* Evidence of hypercoagulable state, Uncontrolled diabetes mellitus, uncontrolled systemic hypertension or pulmonary hypertension at the time of screening or procedure\n* Sensitivity or contraindication to all proposed medical treatments or any device components\n* Pregnant, lactating, or intent on becoming pregnant through 24 months after enrollment.\n* Indications outside the parameters accepted for placement of GSO, including extensive congenital cardiac anomalies and defect diameters considered too large for closure with the device.\n* Atrial septal anatomy that is expected to necessitate placement of more than one GORE® CARDIOFORM Septal Occluder\n* Need for concomitant procedure(s) that may confound detection of adverse events related to device placement\n* Note: Additional Exclusion Criteria may apply","70 Years",{"count":295,"type":19},636,[22],"This study will assess the safety and effectiveness of GORE® CARDIOFORM Septal Occluder in a post approval setting and evaluate the quality of operator education and training and transferability of trial experience to a post-market setting.",[299,300],"Stroke","PFO - Patent Foramen Ovale",[302,303,304,299,305],"Occluder","Patent Foramen Ovale","PFO","Gore Septal Occluder","2026-04-28",{"date":279,"type":34},{"date":309,"type":34},"2019-07-25",{"date":311,"type":19},"2031-10",{"name":40,"class":41},45,{"id":315,"slug":316,"hasResults":11,"nctId":317,"briefTitle":318,"officialTitle":319,"acronym":320,"eligibilityCriteria":321,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":322,"targetDuration":4,"studyType":20,"phases":324,"briefSummary":325,"conditions":326,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":336},"100579722","gore-ascending-stent-graft-in-the-treatment-of-de-novo-type-a-aortic-dissections-100579722","NCT06827990","GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections","Evaluation of the GORE® Ascending Stent Graft in the Treatment of De Novo Type A Aortic Dissections","ARISE III","Inclusion Criteria - Primary Arm:\n\nThe subject is\u002Fhas:\n\n1. De novo Type A aortic dissection (≤30 days from symptom onset to index endovascular procedure) compatible with the treatment requirements of the ASG device.\n2. Primarily intended to be treated by placement of the ASG device in the ascending aorta. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator.\n3. Anatomic compatibility of the ascending aorta required for implanting the ASG device:\n\n   a) Proximal Aortic Landing Zone: i. Primary entry tear must be in the ascending aorta and ≥ 2 cm distal to the most distal coronary artery ostium.\n\n   ii. Total aortic diameter between 27mm - 48mm iii. Landing zone cannot be heavily calcified or thrombosed. b) Distal Aortic Landing Zone: i. Primary entry tear must be in the ascending aorta and ≥ 2 cm proximal to BCA ostium.\n\n   c) Adequate aortic length\n4. The Aortic Treatment Team (as defined by the protocol) attest endovascular repair is in the best interest of the patient AND considers the patient to be high-risk for open surgical repair by meeting at least one of the following criteria:\n\n   1. ≥80 years of age\n   2. Body mass index (BMI) ≥ 35 kg\u002Fm2\n   3. History of Respiratory Insufficiency (defined by home O2 usage, exertional dyspnea, imaging evidence of COPD, previous evidence of compromised pulmonary function tests (PFT) on spirometry or other factors as determined by the Investigator)\n   4. Prior Cardiac Surgery\n   5. Hostile Chest (VARC-2 Definition)\n   6. Clinical Frailty Scale 3-7\n   7. Clinical malperfusion (head, gut, lower extremity)\n   8. Transfusion is not possible (e.g., Jehovah's Witness)\n   9. Renal Dialysis prior to aortic dissection\n   10. Chronic renal insufficiency (eGFR\\\u003C60 without dialysis or other documented history of chronic kidney disease prior to dissection)\n5. Age ≥18 years at time of informed consent signature.\n6. Adequate vascular access via transfemoral or retroperitoneal approach.\n7. Informed Consent Form (ICF) signed by the subject or legally authorized representative.\n8. Agrees to comply with protocol requirements, including imaging and 5-year follow-up, as the subject's condition allows.\n\nExclusion Criteria - Primary Arm\n\nThe subject is\u002Fhas:\n\n1. Mechanical heart valve in the aortic position.\n2. Aortic insufficiency grade 3 or greater confirmed during TEE pre-implant.\n3. Indwelling intravascular device that would interfere with or result in contact with planned repair (e.g., contiguous arch graft, LVAD, TAVR device in continuity with aortic tear).\n4. Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome).\n5. Participation in investigational drug or medical device study within one year of enrollment unless approved by the Sponsor.\n6. Known history of drug abuse within one year of treatment which would affect the ability to obtain follow-up.\n7. Pregnant at time of procedure.\n8. Active infected aorta, mycotic aneurysm.\n9. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).\n10. Life expectancy \\\u003C12 months due to presence of another comorbid condition.\n11. Known sensitivities or allergies to the device materials (Previous instance of Heparin Induced Thrombocytopenia type 2 \\[HIT-2\\], known hypersensitivity to heparin, or a history of a hypercoagulability disorder and\u002For state should be considered exclusion if treatment plan includes implant of a TBE device).\n12. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.\n13. Coronary malperfusion.\n14. Catastrophic neurological complications in the 30 days prior to the dissection diagnosis (e.g., progressively worsening symptoms, coma, Glasgow Coma Scale \\\u003C=8).\n15. Aortic fistula.\n16. In circulatory shock (e.g., systolic blood pressure \\\u003C80 mmHg without inotropes, base deficit \\> -10 mmol\u002FL or -10 mEq\u002FL) at any time prior to the initiation of the index endovascular procedure.\n17. In extreme hemodynamic compromise requiring cardiopulmonary resuscitation at any time prior to the initiation of the index endovascular procedure.\n18. Clinical or radiographic signs of bowel infarction, gastrointestinal hemorrhage, or bowel necrosis (as determined by the implanting physician based on imaging observations, peritoneal signs, surgical exploration, elevated serum lactate levels, low pH, and\u002For acidosis) at any time prior to the initiation of the index endovascular procedure.\n\nInclusion Criteria - Secondary Arm\n\nThe subject is\u002Fhas:\n\n1. De novo Type A aortic dissection (≤90 days from symptom onset until first study procedure) compatible with the treatment requirements of the ASG device alone or the ASG device in combination with the TBE device in the Zone 0 position.\n2. Primarily intended to be treated by placement of the ASG device in the ascending aorta or ASG device in combination with the TBE device in the ascending aorta and aortic arch. Distal adjunctive procedures not in contact with the ASG device may be performed during the index endovascular procedure at the discretion of the Investigator.\n3. Anatomic requirements for intended treatment with the ASG device alone or in combination with the TBE device.\n\n   a) Anatomic compatibility required for implanting the ASG device (Intended treatment with ASG device alone) i. Proximal Aortic Landing Zone:\n   1. Primary entry tear must be in the ascending aorta and ≥ 2 cm distal to the most distal coronary artery ostium.\n   2. Total aortic diameter between 27mm - 48mm.\n   3. Landing zone cannot be heavily calcified or thrombosed. ii. Distal Aortic Landing Zone:\n\n   \u003C!-- -->\n\n   1. Primary entry tear must be in the ascending aorta and ≥ 2 cm proximal to BCA ostium.\n\n      iii. Adequate aortic length\n   2. Anatomic compatibility required for implanting the ASG device (Intended treatment with ASG device and TBE device) i. Proximal Aortic Landing Zone:\n\n   \u003C!-- -->\n\n   1. Primary entry tear must be identified in Zone 0-5.\n   2. Landing zone is native aorta.\n   3. Primary entry tear location is ≥2cm distal to the most distal coronary artery ostium.\n   4. Proximal landing zone must be ≥2cm in the ascending aorta.\n   5. Landing zone cannot be heavily calcified or thrombosed.\n   6. Total aortic landing zone diameter 27mm - 48mm. ii. Branch Vessel Landing Zone:\n\n   \u003C!-- -->\n\n   1. Length of ≥2.5 cm proximal to first major branch vessel.\n   2. Target branch vessel inner diameters of 11-18 mm.\n   3. Target branch vessel landing zone must be in native vessel that cannot be heavily calcified or thrombosed.\n   4. The distal 15mm landing zone cannot be dissected.\n4. The Aortic Treatment Team (as defined by the protocol) attest endovascular repair is in the best interest of the patient AND considers the patient to be high-risk for open surgical repair by meeting at least one of the following criteria:\n\n   1. ≥80 years of age\n   2. BMI ≥ 35 kg\u002Fm2\n   3. History of Respiratory Insufficiency (defined by home O2 usage, exertional dyspnea, imaging evidence of COPD, previous evidence of compromised PFTs on spirometry or other factors as determined by the Investigator)\n   4. Prior Cardiac Surgery\n   5. Hostile Chest (VARC-2 Definition)\n   6. Clinical Frailty Scale 3-9\n   7. Clinical malperfusion (head, gut, lower extremity)\n   8. Transfusion is not possible (e.g., Jehovah's Witness)\n   9. Renal Dialysis prior to aortic dissection\n   10. Chronic renal insufficiency (eGFR\\\u003C60 without dialysis or other documented history of chronic kidney disease prior to dissection)\n5. Age ≥18 years at time of informed consent signature.\n6. Adequate vascular access via transfemoral or retroperitoneal approach.\n7. Informed Consent Form (ICF) signed by the subject or legally authorized representative.\n8. Agrees to comply with protocol requirements, including imaging and 5-year follow-up, as the subject's condition allows.\n\nExclusion Criteria - Secondary Arm:\n\nThe subject is\u002Fhas:\n\n1. Mechanical heart valve in the aortic position.\n2. Pregnant at time of procedure.\n3. Active infected aorta, mycotic aneurysm.\n4. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication).\n5. Known sensitivities or allergies to the device materials (Previous instance of Heparin Induced Thrombocytopenia type 2 \\[HIT-2\\], known hypersensitivity to heparin, or a history of a hypercoagulability disorder and\u002For state should be considered exclusion if treatment plan includes implant of a TBE device).\n6. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.",{"count":323,"type":19},112,[22],"To assess the safety and effectiveness of the ASG device in the treatment of de novo Type A aortic dissections.",[327],"Aortic Dissection","2026-04-13",{"date":330,"type":34},"2026-04-14",{"date":332,"type":34},"2025-09-22",{"date":334,"type":19},"2031-09-01",{"name":40,"class":41},16,{"id":338,"slug":339,"hasResults":11,"nctId":340,"briefTitle":341,"officialTitle":342,"acronym":4,"eligibilityCriteria":343,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":344,"targetDuration":4,"studyType":20,"phases":346,"briefSummary":347,"conditions":348,"keywords":351,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":361},"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":345,"type":19},165,[22],"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.",[214,215,216,217,218,219,220,221,349,350],"Vein Occlusion","Vein Disease",[224,223,225,219,226,220,229,228,215,230,352,231,232,233,234],"Venous disease treatment Options","2026-04-07",{"date":355,"type":34},"2026-04-09",{"date":357,"type":34},"2023-03-02",{"date":359,"type":19},"2031-03",{"name":40,"class":41},27,{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":370,"targetDuration":4,"studyType":20,"phases":372,"briefSummary":373,"conditions":374,"keywords":379,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":394,"locationsCount":395},"100417629","gore-enform-biomaterial-product-study-100417629","NCT04718168","GORE® ENFORM Biomaterial Product Study","GORE® ENFORM Biomaterial Product Study: A Study to Describe Multi-use Biomaterial Performance in Hernia Patients","ENF 18-06","Pre-procedure Inclusion Criteria:\n\nThe subject is \u002F has:\n\n1. At least 18 years old at the time of informed consent. Minimum age required by state regulations (as applicable).\n2. An expected scored Class I (Clean) surgical wound using CDC Surgical Wound Classification system.\n3. A planned implant with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture line reinforcement.\n4. An expected scored Grade 1 or Grade 2 using the Ventral Hernia Working Group Grading system.\n5. Willing to provide informed consent and comply with follow-up requirements.\n\nPre-procedure Exclusion Criteria:\n\nThe subject is \u002F has:\n\n1. Treated in another drug or medical device study within 1 year of study enrollment.\n2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.\n3. Hernia repair expected to be performed as part of a bridged procedure (i.e., expected inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).\n4. A BMI \\>40.\n5. Evidence of a systemic infection.\n6. Cirrhosis or undergoing dialysis.\n7. A wound-healing disorder.\n8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.\n9. Expected to undergo mesh implantation in conjunction with any bariatric procedure and \u002F or panniculectomy procedure.\n10. A stoma.\n11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\n12. Positive pregnancy or lactation status as confirmed by site standard of care.\n13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.\n\nPost-procedure Inclusion Criteria\n\nAt the time of index procedure, the subject is \u002F has:\n\n1. At least 18 years old. Minimum age required by state regulations (as applicable).\n2. Implanted with GORE® ENFORM Biomaterial for a single site ventral or hiatal hernia repair as suture-line reinforcement on or before 365 days prior to site protocol amendment 3 approval date.\n3. Unless there is an Informed Consent waiver issued by the Institutional Review Board (IRB), an Informed Consent Form (ICF) signed by subject.\n\nPost-procedure Exclusion Criteria\n\nAt the time of index procedure, the subject is \u002F has:\n\n1. Treated in another drug or medical device study within 1 year of study enrollment.\n2. Implanted with GORE® ENFORM Biomaterial in the reconstruction of cardiovascular defects.\n3. Hernia repair that was performed as part of a bridged procedure (i.e., inability to perform primary closure of fascia or crura, patients requiring permanent support from the device).\n4. A BMI \\>40.\n5. Evidence of a systemic infection.\n6. Cirrhosis or undergoing dialysis.\n7. A wound-healing disorder.\n8. Immunocompromised such as, with HIV or transplant, or receiving chemo or radiation therapy.\n9. Underwent mesh implantation in conjunction with any bariatric procedure and \u002F or panniculectomy procedure.\n10. A stoma.\n11. Co-morbid conditions that may limit their ability to comply with study and follow-up requirements.\n12. Positive pregnancy or lactation status as confirmed by site standard of care.\n13. Hernias requiring treatment within multiple body regions or expected use of multiple hernia mesh devices.",{"count":371,"type":19},245,[22],"A prospective, retrospective, non-randomized, multicenter study with two independent hernia study cohorts (Ventral \u002F Incisional Hernia Repair and Diaphragmatic \u002F Hiatal Hernia Repair). The primary objective of this study is to collect GORE® ENFORM Biomaterial product commercial-use data on device functional performance and short-term patient experience.",[375,376,377,378],"Hernia, Ventral","Hernia, Hiatal","Hernia, Diaphragmatic","Incisional Hernia",[380,381,382,383,384,385,226,386,387],"hernia","ventral","hiatal","diaphragmatic","incisional","mesh","W.L. Gore","Enform","2026-02-17",{"date":390,"type":34},"2026-02-18",{"date":392,"type":34},"2021-05-17",{"date":149,"type":19},{"name":40,"class":41},9,{"id":397,"slug":398,"hasResults":11,"nctId":399,"briefTitle":400,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":403,"targetDuration":405,"studyType":53,"phases":4,"briefSummary":406,"conditions":407,"keywords":411,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":4},"100622955","viatorr-tips-study-evaluating-6-10mm-diameters-viatips-100622955","NCT07390344","VIATORR® TIPS Study Evaluating 6-10mm Diameters (VIATIPS)","VIATIPS","Inclusion Criteria:\n\n1. The subject is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion 6-10mm for de novo TIPS creation.\n2. The subject has cirrhotic portal hypertension.\n3. The subject is ≥18 years of age.\n4. The subject is capable of complying with protocol requirements, including follow up.\n5. The subject or legal representative signed the informed consent form (ICF).\n\nExclusion Criteria:\n\n1. The subject has any portal vein thrombosis, including both occlusive and non-occlusive thrombosis.\n2. The subject has received a liver transplantation. Patients on the transplant list are still eligible.\n3. The subject has a life expectancy of less than 6 months.\n4. The subject has extrahepatic or hepatic malignancy or a history of previous malignancy, unless treated curatively ≥5 years prior to enrollment. Subjects with non-melanoma skin cancer and\u002For carcinoma in situ of the cervix remain eligible.\n5. The subject has inadequate functional hepatic reserve with a Model for End-Stage Liver Disease (MELD) Score of \\> 25 or Child Pugh Score of \\> 14.\n6. The subject is enrolled in another investigational study, unless agreed in advance in writing by the Sponsor.\n7. The subject is pregnant at the time of informed consent signature.\n8. The subject has any other condition which in the judgement of the investigator would preclude adequate Study participation.",{"count":404,"type":19},152,"2 Years","This Registry will look at patients being treated with a transjugular intrahepatic portosystemic shunt (TIPS) procedure for portal hypertension. The purpose of this Registry is to collect data on the safety and performance of the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (6-10mm) for 2 years in real world setting.\n\nAdditionally, data will be collected on the safety and performance of the GORE TIPS Set when utilized.",[408,409,410],"Ascites","Variceal Bleeding","Portal Hypertension Related to Cirrhosis",[412,413,414,415,416],"portal hypertension","TIPS","cirrhosis","decompensated","Transjugular Intrahepatic Portosystemic Shunt","2026-02-05",{"date":419,"type":34},"2026-02-10",{"date":421,"type":19},"2026-06",{"date":423,"type":19},"2029-09-30",{"name":40,"class":41},{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":432,"targetDuration":272,"studyType":53,"phases":4,"briefSummary":434,"conditions":435,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":439,"completionDateStruct":441,"leadSponsor":443,"locationsCount":125},"100596779","tbe-zone-2-pms-in-japan-100596779","NCT07049913","TBE Zone 2 PMS in Japan","GORE® TAG® Thoracic Branch Endoprosthesis Zone 2 Post-Market Surveillance in Japan","Inclusion Criteria:\n\n* Those who are suitable for use of TBE according to the Japan package insert.\n\n\\[Reference: Purpose of Use or Effects of TBE at the time of launch\\] The GORE TAG Thoracic Branch Endoprosthesis is intended for use in patients with the following diseases with descending thoracic aortic lesions who fulfill anatomical requirements for treatment of such diseases while preserving blood flow to the left subclavian artery.\n\n* Thoracic aortic aneurysm,\n* Traumatic transection, and\n* Complicated Stanford type B aortic dissection (including dissecting aortic aneurysm) who have not responded to medical therapy.\n\nExclusion Criteria:\n\n* N\u002FA",{"count":433,"type":19},200,"The goal of this surveillance is to confirm the TBE device's safety and efficacy in patients treated with proximal landing in Zone 2 in the post-marketing period.",[60,436,104],"Dissection of Aorta, Thoracic","2026-02-04",{"date":417,"type":34},{"date":440,"type":34},"2025-12-15",{"date":442,"type":19},"2034-02",{"name":40,"class":41},{"id":445,"slug":446,"hasResults":11,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":451,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":469},"100532904","endovascular-aaa-intervention-using-the-gore-excluder-conformable-aaa-endoprosthesis-or-iliac-branch-endoprosthesis-100532904","NCT06218875","Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis","Assessment of Long Term, Endovascular AAA Intervention Using the GORE® EXCLUDER® Conformable AAA Endoprosthesis or Iliac Branch Endoprosthesis","Inclusion Criteria:\n\n1. Patient or legally authorized representative (LAR) provides written authorization and\u002For consent per institution and geographical requirements\n2. Patient has been or is intended to be treated with an eligible registry device\n3. Patient is age ≥ 18 years at time of informed consent signature.\n\nExclusion Criteria:\n\n1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.\n2. Patient with exclusion criteria required by local law.\n3. Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.",{"count":452,"type":19},2000,"A prospective, observational post-market registry collecting outcomes through a 10-year post procedure follow-up for patients treated with the GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC Device) or the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device) as a part of routine clinical practice.",[455],"AAA - Abdominal Aortic Aneurysm",[102,457,65,458,459,460,461],"Aneurysm Repair","EVAR","Endoprosthesis","Aortic","Aortic Repair","2026-02-02",{"date":417,"type":34},{"date":465,"type":34},"2024-05-07",{"date":467,"type":19},"2042-09-30",{"name":40,"class":41},90,{"id":471,"slug":472,"hasResults":11,"nctId":473,"briefTitle":474,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":11,"sex":15,"minAge":476,"maxAge":4,"enrollmentInfo":477,"targetDuration":4,"studyType":20,"phases":478,"briefSummary":479,"conditions":480,"keywords":483,"overallStatus":144,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":494,"leadSponsor":496,"locationsCount":4},"100616322","assessment-of-gore-excluder-ibe-plus-stent-graft-performance-in-patients-undergoing-endovascular-iliac-revascularization-100616322","NCT07304102","Assessment of GORE® EXCLUDER® IBE Plus Stent Graft Performance in Patients Undergoing Endovascular Iliac Revascularization","Primary Arm Inclusion Criteria\n\nThe subject is \u002F has:\n\n1. The target lesion and surrounding vasculature are amenable to treatment with IBE Plus system requirements:\n\n   1.1. Common iliac artery to be treated must have a common iliac diameter ≥ 25 mm with or without concomitant abdominal aortic aneurysm 1.2. Minimum diameter ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.3. Intended treatment length must be ≥ 100 mm in unilateral application or a combination of ≥ 100 mm and ≥ 150 mm in bilateral application 1.4. The planned distal target landing zone within the internal iliac artery is within the trunk of the internal iliac artery with at least 15 mm of seal zone 1.5. Iliac vasculature meets anatomical specifications for selected VBX Stent Graft(s)\n2. Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices\n3. Informed Consent Form (ICF) is signed by subject\n4. Subject is capable of complying with protocol requirements, including follow-up\n5. Life expectancy \\> 2 years\n6. Age ≥ 22 years at time of informed consent signature\n7. Male or infertile female\n\nSecondary Arm Inclusion Criteria\n\nThe subject is \u002F has:\n\n1. Present with any one of the following treatment indications:\n\n   1.1. The subject has a confirmed Type Ib endoleak of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. Minimum diameter of ≥ 12 mm within the proximal implantation zone of IBE Plus as assessed by flow lumen; calcium excluded 1.2. The subject has documented diameter growth of the common iliac artery of at least ≥ 5 mm in the presence of a previously implanted Gore EVAR device where its distal portion within the common iliac artery has a luminal diameter of at least 12 mm. The planned distal target landing zone within the internal iliac artery is within the trunk of the internal iliac artery with at least 15 mm of seal zone\n2. Aortoiliac vasculature meets anatomical specifications for selected EXC or EXCC Devices\n3. Informed Consent Form (ICF) is signed by subject\n4. Subject is capable of complying with protocol requirements, including follow-up\n5. Life expectancy \\> 2 years\n6. Age ≥ 22 years at time of informed consent signature\n7. Male or infertile female\n\nPrimary Arm and Secondary Arm Exclusion Criteria\n\nThe subject is \u002F has:\n\n1. Mycotic or ruptured aneurysm\n2. ASA class V (moribund patient not expected to live 24 hours with or without operation)\n3. Renal insufficiency defined as creatinine \\> 1.8 mg\u002FdL or undergoing dialysis\n4. NYHA class IV\n5. Dissected, heavily calcified, or heavily thrombosed landing zone(s)\n6. Tortuous or stenotic iliac and\u002For femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access\n7. Participating in another investigational drug or medical device study within one year of study enrollment\n8. An active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection. Subjects with a chronic infection (such as HIV, Hepatitis C, etc.) that is well controlled under their current treatment regimen may be eligible\n9. Degenerative connective tissue disease, e.g., Marfan's or Ehler-Danlos Syndrome\n10. Planned concomitant surgical procedure or major surgery within 30 days of treatment date\n11. History of drug abuse, e.g., cocaine or amphetamine, within 1 year of treatment\n12. Known sensitivities or allergies to the device materials","22 Years",{"count":271,"type":19},[22],"The IBE 25-05 study will be a prospective, non-randomized, multicenter, interventional two arm evaluation designed to assess the safety and effectiveness of the GORE® EXCLUDER® IBE Plus Stent Graft in patients with common iliac artery aneurysm (CIAA) or aorto-iliac aneurysm (AIAA) disease.",[481,482],"Common Iliac Artery Aneurysm","Aorto Iliac Aneurysm",[484,458,485,486,487,488,489],"EVAR Revision","Endovascular Aneurysm Repair","AIAA","CIAA","IBE","Iliac Aneurysm","2025-12-23",{"date":492,"type":34},"2025-12-26",{"date":149,"type":19},{"date":495,"type":19},"2032-08",{"name":40,"class":41},{"id":498,"slug":499,"hasResults":11,"nctId":500,"briefTitle":501,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":503,"enrollmentInfo":504,"targetDuration":4,"studyType":20,"phases":506,"briefSummary":507,"conditions":508,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":513,"lastUpdatePostDateStruct":514,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":521},"100414067","a-study-to-evaluate-the-safety-and-effectiveness-of-the-innavasc-arteriovenous-graft-for-hemodialysis-access-in-patients-with-end-stage-renal-disease-100414067","NCT04671771","A Study to Evaluate the Safety and Effectiveness of the InnAVasc Arteriovenous Graft for Hemodialysis Access in Patients With End-Stage Renal Disease","Inclusion Criteria:\n\nPre-Operative Inclusion Criteria:\n\nPatients must meet the following criteria at screening in order to be scheduled for a procedure and potentially enrolled in the study:\n\n1. Patients with ESRD whose next most appropriate option for AV access is placement of an AV graft to start or maintain hemodialysis therapy;\n2. Age 18 to 90 years old, inclusive;\n3. Suitable anatomy for implantation of upper arm \"straight\" or looped graft, or forearm looped graft (graft not to cross the bend of the elbow);\n4. Ability to continue or commence antiplatelet therapy post graft implant (anticoagulation medication is acceptable if the subject is required to take an anticoagulant for a baseline medical condition);\n5. Able and willing to give informed consent;\n6. Anticipated life expectancy of at least 1 year.\n\nIntra-Operative Inclusion Criteria:\n\nBoth vessels have been exposed and are deemed appropriate for implantation (i.e., based on the surgeon's opinion, artery is of adequate size, has adequate pulse to support AV access flow, is without significant calcification, and is safely clampable; and the vein is of adequate size, free of localized sclerosis, and is free of immediate outflow obstruction).\n\nPre-Operative Exclusion Criteria:\n\nPatients will be excluded from the study at screening if they exhibit any of the following exclusion criteria:\n\n1. History or evidence of severe cardiac disease (i.e., debilitating heart failure, or high risk of MI) in the opinion of the investigator which may preclude participation in and completion of the study;\n2. Uncontrolled diabetes in the opinion of the investigator (i.e., multiple recent diabetes related hospitalizations);\n3. For upper arm straight configuration, an antecubital fossa crease to axillary crease distance \\\u003C 18 cm;\n4. History or evidence of severe peripheral arterial disease in the extremity selected for implant (i.e., arterial inflow insufficient to support hemodialysis access);\n5. Known or suspected central vein stenosis or obstruction on the side of planned graft implantation;\n6. Baseline hypotension or history of frequent hypotensive episodes during dialysis that, in the opinion of the investigator, puts the patient at increased risk of graft thrombosis;\n7. Uncontrolled hypertension, per the opinion of the investigator (i.e., recent history of recurrent hospitalizations for hypertensive related illness);\n8. Baseline hemoglobin \\\u003C7 g\u002FdL;\n9. Baseline platelet count \\\u003C50,000 or \\>500,000 cells\u002Fmm3;\n10. Documented history of stroke within 6 months prior to enrollment;\n11. Treatment with any investigational drug or device within 30 days prior to enrollment;\n12. Female patients who are pregnant, intending to become pregnant, nursing or intending to breastfeed during the study (pregnancy test may only be omitted, if patient is post-menopausal or has a documented history of hysterectomy or permanent sterilization);\n13. History of cancer with active disease or treatment within the previous year, except for non-invasive basal or squamous cell carcinoma of the skin;\n14. Immunodeficiency including documented history of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) or patients receiving immunosuppressive therapy for treatment of an acute inflammatory event or autoimmune flare. Chronic immunosuppressive therapy is acceptable;\n15. Documented or suspected hypercoagulable condition;\n16. Bleeding diathesis, other than that associated with ESRD;\n17. Documented history of heparin-induced thrombocytopenia (HIT);\n18. Active local or systemic infection as documented from the medical history or bloodwork\u002Fblood culture data. If the infection resolves, the subject must be at least one-week post resolution of that infection before implantation;\n19. Scheduled renal transplant within 6 months;\n20. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and effectiveness of the IG;\n21. Patient is unable or unwilling to complete all required follow-up assessments and questionnaires.","90 Years",{"count":505,"type":19},133,[22],"The goal of the CSP-2002 clinical trial is to evaluate the safety and effectiveness of the InnAVasc Arteriovenous Graft (IG) for hemodialysis (HD) access in patients with end-stage renal disease (ESRD). The primary study endpoints are:\n\nPrimary Effectiveness Endpoint: The proportion of subjects with secondary patency at 6 months.\n\nPrimary Safety Endpoint: The incidence of device-related adverse events of special interest (AESIs) through 6 months.\n\nParticipants will be asked to sign an informed consent form. Once enrolled, they will be assessed to receive the study graft implant and asked to participate in periodic follow-up visits and assessments through 2 years following implant.",[509,510,511,512],"End Stage Renal Disease (ESRD)","Kidney Failure","Chronic Renal Disease","Hemodialysis","2025-12-18",{"date":515,"type":34},"2025-12-22",{"date":517,"type":34},"2020-12-03",{"date":519,"type":19},"2029-07-01",{"name":40,"class":41},21,{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":20,"phases":531,"briefSummary":532,"conditions":533,"keywords":535,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":545},"100529484","clinical-outcomes-of-the-gore-synthetic-cornea-device-100529484","NCT06174376","Clinical Outcomes of the Gore Synthetic Cornea Device","A Prospective, Multi-Center, Early Feasibility Study to Assess Clinical Outcomes of the GORE Synthetic Cornea Device in Patients With Loss of Corneal Clarity","Key Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be eligible to be consented for this study.\n\n  1. Patient must be able to comprehend the study requirements and provide written informed consent. Patients must be willing to follow study instructions, agree to comply with all study procedures , and able to return for all scheduled follow-up examinations for 12 months postoperatively (the study duration). The follow-up exams may be extended up to 60 months post operatively if the patient consents to the extension.\n  2. Male or female patients ≥ 18 years old at the time of consent\n  3. Physical condition suitable for undergoing surgery, as evidenced by medical history and physical examination provided by a licensed medical provider (primary care physician, nurse practitioner, internal medicine physician etc.)\n  4. Currently with an opaque cornea (as determined by the investigator) with or without a prior history of failed donor corneal transplantation \\[penetrating keratoplasty (PK) or endothelial keratoplasty (EK)\\] and loss of corneal clarity\n  5. Best corrected distance visual acuity of worse than 20\u002F400 in the study eye using Snellen chart\n  6. Best corrected distance visual acuity of better than 20\u002F200 in the fellow (non-study) eye using Snellen chart\n  7. Pseudophakia status in the study eye with a stable posterior chamber intraocular lens (IOL) implant centered within the capsular bag or sulcus\n  8. Corneal thickness measurement in study eye (epithelium to endothelium; central and mid-peripheral\u002F 3 to 5mm away from center at superior, inferior, nasal and temporal quadrants) with each measurement between 700um - 900um, measured using ultrasound (US) pachymetry. If one or more measurements cannot be obtained using US pachymetry, measurements using anterior segment optical coherence tomography (OCT) may be used (with the measurement being between 700-900um)\n  9. If applicable, prior corneal transplant ≥ 8 mm in diameter\n  10. Adequate lid function and normal ocular surface and tear film parameters for implant of the study device, as determined by the investigator.\n\nKey Exclusion Criteria:\n\n* Patients who meet any of the following exclusion criteria cannot be consented and included in this study:\n\n  1. Inability to provide written informed consent and comply with study assessments for the full duration of the study.\n  2. Age: \\\u003C 18 years\n  3. Patients who are pregnant\u002Fnursing or planning to become pregnant during the study.\n\n     Note: For women of child-bearing potential, confirmation of pregnancy status must be documented per site standard.\n  4. Corneal thickness measurement (epithelium to endothelium; central and mid-peripheral\u002F 3 to 5mm away from center at superior, inferior, nasal and temporal quadrants) in the study eye with any measurement less than 700um or more than 900um measured using US pachymetry. If one or more measurements cannot be obtained using US pachymetry, measurements using anterior segment OCT may be used\n  5. If applicable, prior corneal transplant \\\u003C 8 mm in diameter\n  6. Aphakic or phakic status of the study eye\n  7. Pseudophakic status of the study eye with anterior chamber IOL or unstable posterior chamber IOL, according to clinical history or UBM\n  8. Evidence of tear film, ocular surface or lid abnormalities in the study eye\n\n     * Schirmer test without anesthesia less than 5 mm at 5 minutes. NOTE: Patient can be eligible after successful tear duct blockage (such as plugs or cauterization) if the Schirmer's are adequate following the procedure\n     * Evidence of conjunctival or lid margin keratinization\n     * Presence of cicatrizing conjunctivitis (Stevens Johnson Syndrome, mucous membrane pemphigoid, trachoma, chemical, radiation or thermal trauma\n     * Prior history of stage II or III neurotrophic keratitis \u002F keratopathy\n     * Limbal stem cell deficiency leading to prior episode(s) of recurrent or persistent corneal epithelial defects\n     * Prior history of immune-mediated\u002F non-infectious keratolysis with or without underlying systemic disease\n     * Significant lid margin disease with infestation\u002Finfection within 30 days prior to surgery.\n\n     NOTE: Patient can be eligible after successful treatment and resolution\n     * Significant anatomical lid problems (trichiasis, entropion, ectropion, lagophthalmos, exophthalmos, Bell's palsy, or significant ptosis)\n  9. Current or history of corneal or ocular surface infection in the study eye within 30 days prior to surgery.\n\n     NOTE: Patient can be eligible after successful treatment and resolution as determined by the investigator\n  10. Any known intolerance or hypersensitivity to topical anesthetics, mydriatics, post-operative antibiotic or steroid drops , topical intraocular pressure lowering drops, allergy to sulfa drugs, or inability to tolerate oral intraocular pressure lowering drugs, or any component of the device\n  11. History of ocular or periocular malignancy in the study eye within the previous five years\n  12. Current or prior history of herpes simplex virus (HSV) or Varicella-zoster virus (VZV) keratitis in the study eye.\n  13. History of shingles vaccination in the past year or intent to receive the vaccine during the study period\n  14. Current or prior history of uveitis in the study eye\n  15. Current or prior history of scleritis or retinitis in the study eye\n  16. Uncontrolled glaucoma defined by having one or both of the below:\n\n      * Intraocular pressure of greater than 21 mm Hg\n      * Intraocular pressure above the specific target pressure for the patient NOTE: Patients with history of glaucoma who are on topical glaucoma medications or who have undergone glaucoma surgery with intraocular pressure within the target range are eligible\n  17. Hypotony in the study eye, as evidenced by an intraocular pressure of \\\u003C 6 mmHg\n  18. Presence of broad anterior synechia greater than a quadrant, defined by having both of the below:\n\n      * 3 contiguous clock hours of synechia\n      * Involving the central 8 mm of the cornea\n  19. Presence of significant corneal stromal vascularization, defined by having both of the below:\n\n      * 3 contiguous clock hours of vascularization\n      * Involving the central 8 mm of the cornea\n  20. Retinal detachment within 30 days prior to surgery. NOTE: Patients with a prior history of retinal detachment surgery are eligible, unless they currently have silicone oil in the posterior segment\n  21. Current (or prior) history of other keratoprosthesis device implantation\n  22. Monocular status\n  23. Inability to wear a soft contact lens due to conjunctival or lid abnormalities\n  24. Signs of current (within the two weeks prior to surgery) systemic infection, including fever and current treatment with antibiotics\n  25. Participation in another simultaneous interventional medical investigation or trial that may have a reasonable likelihood of affecting the outcomes of the present study\n  26. Have any other history of clinically severe diseases, or conditions that in the opinion of the investigator, may affect the results of the study\n  27. Any current or history of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication or adherence to study procedures\n  28. Patients who are unable to comply with the study procedures and follow-up visits throughout the study period (12 months)",{"count":530,"type":19},10,[22],"Study objective is to evaluate the initial safety and effectiveness of the GORE Synthetic Cornea Device in the treatment of loss of corneal clarity in patients who are candidates for corneal transplantation",[534],"Corneal Opacity",[536],"Artificial Corneal transplantation, corneal opacity, corneal blindness","2025-12-03",{"date":539,"type":34},"2025-12-04",{"date":541,"type":34},"2024-08-19",{"date":543,"type":19},"2030-12-31",{"name":40,"class":41},2,{"id":547,"slug":548,"hasResults":11,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":11,"sex":553,"minAge":476,"maxAge":4,"enrollmentInfo":554,"targetDuration":4,"studyType":20,"phases":556,"briefSummary":557,"conditions":558,"keywords":560,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":134},"100558863","tissue-reinforcement-for-breast-reconstruction-trbr-pivotal-clinical-study-redefine-100558863","NCT06556654","Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)","Evaluation of the Safety and Effectiveness of the GORE® Tissue Reinforcement for Breast Reconstruction Device (TRBR Device) When Used in the Reinforcement of Breast Reconstruction","Inclusion Criteria:\n\n1. Female subjects ≥ 22 years of age.\n2. First-time breast reconstruction post-mastectomy for target breast(s).\n3. Scheduled to undergo unilateral or bilateral mastectomy with immediate, two-stage, implant-based, subpectoral or prepectoral breast reconstruction after mastectomy.\n4. Mastectomy performed to address breast cancer or for cancer prophylaxis.\n5. An informed consent form is signed by Subject or Legally Authorized Representative (LAR).\n6. Subject is capable of following protocol procedures and complying with follow-up visit requirements\n\nExclusion Criteria:\n\nBaseline Exclusion Criteria\n\n1. Subject has had a revision(s) in the target breast(s) following complications of breast augmentation, mastopexy (breast lift), or breast reduction.\n2. Subject has undergone previous radiation therapy to the reconstruction site or chest wall.\n3. Subject has had chemotherapy within 3 weeks prior to the index procedure.\n4. Subject has been treated for a systemic infection or local infection at the surgical site within 30 days prior to index procedure.\n5. Subject has a current or previous diagnosis of Methicillin-resistant Staphylococcus aureus (MRSA).\n6. Subject has a BMI \\> 35.\n7. Subject has a known diagnosis of diabetes with a HbA1c \\> 7.0mmol\u002FL within 30 days of the Index procedure (i.e., TE placement).\n8. Subject was a current or former tobacco\u002Fnicotine user, within 90 days prior to Index Surgery (i.e., TE placement).\n9. Subject is currently taking medication (e.g., systemic steroid), which in the investigator's opinion, may increase the risk of local complications of breast reconstruction.\n10. Subject has other medical, social, or psychological conditions which could interfere with provision of informed consent, completion of tests, therapy, or follow-up.\n11. Subject is currently participating in or planning to participate in another investigational drug, biologic or medical device study that may interfere with compliance of TBR 22-07 study requirements or may confound TBR 22-07 study data\u002Foutcomes.\n12. Subject requires a surgical technique requiring flap (autologous tissue).\n13. Subject is pregnant or lactating at the time of the index procedure (i.e., TE placement) or is planning to become pregnant prior to the Exchange procedure. Intraoperative Index Procedure Exclusion\n14. Based on investigator's opinion, subject has unsuitable tissue integrity for immediate 2-stage breast reconstruction or is no longer a candidate to receive the TRBR Device (will be recorded as a screen failure).\n15. Subject receives an Acellular Dermal Matrix (ADM) or mesh that is not the TRBR Device in the target breast(s)","FEMALE",{"count":555,"type":19},180,[22],"The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures. There will be two arms in this study, a Treatment Arm, where data will be collected for a new medical device called the Tissue Reinforcement for Breast Reconstruction (TRBR) Device and a Control Arm where data will be collected from subjects who have previously had surgery and received no additional tissue reinforcement in their breast reconstruction surgery. This research study will look at the safety of the Study Device and the success of the participants breast reconstruction. The Study Device is investigational, which means it has not yet been used nor approved by the FDA for this treatment. The data collected in this study will be compared to the data collected in the Control Arm.",[559],"Breast Reconstruction Surgery",[561,562,563,564,565,566,567,568],"breast reconstruction","post-mastectomy","tissue expander","implant based breast reconstruction","two-stage","immediate","subpectoral","prepectoral","2025-10-21",{"date":571,"type":34},"2025-10-23",{"date":573,"type":34},"2025-04-09",{"date":575,"type":19},"2030-07",{"name":40,"class":41},{"id":578,"slug":579,"hasResults":11,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":585,"targetDuration":587,"studyType":53,"phases":4,"briefSummary":588,"conditions":589,"keywords":592,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":601,"leadSponsor":603,"locationsCount":285},"100504305","registry-of-gore-acuseal-vascular-graft-in-dialysis-access-100504305","NCT05846581","Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access","Observational Prospective Post-Market Clinical Follow-Up (PMCF) Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access","AVG22-09","Inclusion Criteria:\n\n1. The patient requires the creation of vascular access for hemodialysis secondary to a diagnosis of End-Stage Renal Disease and intends to use GORE® ACUSEAL Vascular Graft device for arteriovenous (AV) access.\n2. Age ≥18 years at time of Informed Consent Form (ICF) signature.\n3. Willingness of the patient to adhere to institutional standard of care follow-up.\n4. Informed Consent Form (ICF) is signed by the patient.\n5. The patient is currently on hemodialysis or intended to begin hemodialysis immediately following placement of the GORE® ACUSEAL Vascular Graft device or up to 30 days following placement of the device.\n6. The patient has a reasonable expectation of remaining on hemodialysis for 12 months.\n\nExclusion Criteria:\n\n1. The patient currently has a known or suspected systemic infection.\n2. The patient is pregnant or breastfeeding.\n3. The patient had a separate interventional or surgical vascular procedure within the study limb within 30 days prior to treatment with the GORE® ACUSEAL Vascular Graft device.\n4. The patient had a previous documented (via imaging technique) and unsuccessfully treated ipsilateral central venous stenosis.\n5. The patient is currently taking maintenance corticosteroids and immunosuppressant medication such as rapamycin, mycophenolate or mycophenolic acid, prednisone (\\> 10 mg), cyclosporine, tacrolimus, or cyclophosphamide.\n6. The patient has a known hypercoagulability or bleeding disorder.\n7. The patient has had a previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or has known sensitivity to Heparin.\n8. The patient is enrolled in an investigational study.\n9. The patient has been previously enrolled in this registry.\n10. The patient is currently being considered for a live donor kidney transplant (living donor either related or unrelated to patient).\n11. The patient has life expectancy less than 2 years.",{"count":586,"type":19},72,"24 Months","The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are:\n\n* Safety: Freedom from device-related infection adverse events at 24 months from device implant\n* Performance: Secondary patency at 24 months from device implant.\n\nParticipants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.",[590,591],"Chronic Kidney Diseases","End Stage Renal Disease on Dialysis",[593,590,594,512,595],"Post-Market Clinical Follow-Up","End Stage Renal Disease","vascular graft","2025-07-08",{"date":598,"type":34},"2025-07-09",{"date":600,"type":34},"2024-01-12",{"date":602,"type":19},"2027-10-27",{"name":40,"class":41},{"id":605,"slug":606,"hasResults":11,"nctId":607,"briefTitle":608,"officialTitle":609,"acronym":4,"eligibilityCriteria":610,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":611,"targetDuration":405,"studyType":53,"phases":4,"briefSummary":612,"conditions":613,"keywords":616,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":134},"100555113","post-market-registry-for-gore-tag-thoracic-branch-endoprosthesis-100555113","NCT06507865","Post Market Registry for GORE® TAG® Thoracic Branch Endoprosthesis","Characterization of Mid-term Post Market Clinical Follow Up of GORE® TAG® Thoracic Branch Endoprosthesis Facilitated Aortic Arch and Descending Aorta Intervention","Inclusion Criteria:\n\nPatient or legally authorized representative (LAR) provides written authorization and\u002For consent per institution and geographical requirements Patient has been or is intended to be treated with an eligible registry device Patient is age ≥ 18 years at time of informed consent signature.\n\nExclusion Criteria:\n\nPatient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.\n\nPatient with exclusion criteria required by local law. Patient is currently enrolled in or plans to enroll in any concurrent drug and\u002For device study within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.",{"count":433,"type":19},"The goal of this observational study is to collect mid-term post-market clinical follow-up data of GORE® TAG® Thoracic Branch Endoprosthesis used according to the standard medical practice in patients presenting with vascular disease. This registry aims to answer questions related to the efficacy and safety of GORE® TAG® Thoracic Branch Endoprosthesis.",[102,614,615,138,62],"Dissection, Aortic","TAA Thoracoabdominal Aortic Aneurysm",[617,102,57,618,619,620],"TEVAR","Aorta","Endovascular stent graft","Thoracic branch endoprosthesis","2025-05-05",{"date":623,"type":34},"2025-05-09",{"date":625,"type":34},"2025-02-20",{"date":627,"type":19},"2031-04",{"name":40,"class":41},""]