[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05800743":3,"trial-entities:NCT05800743":404,"trial-summary:NCT05800743":411},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":54,"secondary_outcomes":62,"sex":71,"minimum_age":72,"maximum_age":17,"healthy_volunteers":73,"eligibility_criteria":74,"std_ages":80,"locations":83,"central_contacts":396,"overall_officials":397,"references":402,"see_also_links":403},"NCT05800743","ASG 22-02","Evaluation of the GORE® Ascending Stent Graft","Evaluation of the GORE® Ascending Stent Graft in the Treatment of Lesions of the Ascending Aorta","ENROLLING_BY_INVITATION","2034-01","2026-05","2026-05-29","2023-11-28","W.L.Gore & Associates","INDUSTRY",true,"The primary objective of ARISE II is to assess the safety and effectiveness of the GORE® Ascending Stent Graft device in the treatment of lesions involving the ascending aorta and aortic arch.",null,[19,20,21,22],"Aortic Aneurysm, Thoracic","Pseudoaneurysm","Aortic Dissection","Aorta; Lesion",[24,20,25,26,19],"Ascending Aorta","Aortic Lesion","Endovascular Repair","INTERVENTIONAL","TREATMENT",[30],"NA",{"count":32,"type":33},370,"ESTIMATED",[35,41,48],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","GORE® Ascending Stent Graft (ASG device)","Endovascular aortic repair of the ascending aorta",[40],"ASG device only in Ascending Aorta",{"type":36,"name":42,"description":43,"armGroupLabels":44,"otherNames":46},"GORE® Thoracic Aortic Graft Thoracic Branch Endoprosthesis (TBE Device)","Endovascular aortic repair of the ascending aorta\u002Faortic arch",[45],"ASG + TBE",[47],"Revascularization Procedure",{"type":49,"name":50,"description":51,"armGroupLabels":52},"PROCEDURE","Surgery","Open surgical repair of the ascending aorta and\u002For the aortic arch",[53],"Surgical Follow-up Cohort",[55,59],{"measure":56,"description":57,"timeFrame":58},"Primary effectiveness endpoint as measured by device technical success and absence of reintervention.","The primary effectiveness endpoint is a composite of the following events through one month post procedure: Device Technical Success and Absence of Reintervention.\n\nTechnical Success is defined as including:\n\n1. Successful access and delivery to the intended implantation site, and retrieval of the device delivery system, and;\n2. Accurate placement of the device at the intended implantation site, and\n3. Patency of the graft in absence of clinically significant device deformations (e.g., kinking, stent eversion, mal-deployment, misaligned deployment), and\n\nAbsence of reintervention is defined as: The absence of unanticipated additional procedures related to the device, procedure, or withdrawal of the delivery system","30 Days",{"measure":60,"description":61,"timeFrame":58},"Primary Safety Endpoint as measured by a composite of the absence of aortic rupture, lesion-related mortality, disabling stroke, permanent paraplegia, permanent paraparesis, and new onset renal failure requiring permanent dialysis.","The primary safety endpoint is a composite of the following events through 30 days post endovascular procedure:\n\n* Aortic rupture\n* Lesion-related mortality\n* Disabling Stroke\n* Permanent paraplegia\n* Permanent paraparesis\n* New onset renal failure requiring permanent dialysis",[63,67],{"measure":64,"description":65,"timeFrame":66},"Secondary endpoints as measured as a composite of procedural and treatment success.","Two secondary endpoints are planned for the study with no inferential analysis. Composite endpoint of procedural success elements measured at one month follow-up Composite endpoint of treatment success elements measured at all appropriate follow-up windows","30 Days, and 6, 12, 24, 36, 48 and 60 months",{"measure":68,"description":69,"timeFrame":70},"Secondary endpoint as measured by Short Form-36® physical component summary (PCS)","Short Form-36® PCS measured at the one year follow-up visit with inferential analysis","12 months","ALL","18 Years",false,{"inclusion":75,"exclusion":78,"raw_text":79},[76,77],"Chronic de novo aortic dissection with primary entry tear in the ascending aorta or arch","Chronic de novo aortic dissection with primary entry tear in the descending thoracic aorta with retrograde involvement of the aortic arch and\u002For ascending aorta 7. Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (\\>30 days post-surgery) 2. Anatomic compatibility with ASG device used in combination with the TBE Device based on Gore Imaging Sciences review.",[],"Inclusion Criteria: ASG Device Alone Arm\n\nThe patient is\u002Fhas:\n\n1. Ascending Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device meeting any of the following criteria: Aneurysm\n\n   1. Fusiform aneurysm (≥50mm or documented growth rate \\>0.5cm\u002Fyear)\n   2. Saccular aneurysm (no diameter criteria)\n   3. Pseudoaneurysms (\\>30 days post-surgery, no diameter criteria) Non-aneurysm\n   4. Penetrating Aortic Ulcers (PAUs) (no diameter criteria)\n   5. Pseudoaneurysms, following open surgical repair of a Type A dissection (\\>30 days post-surgery, no diameter criteria)\n2. Anatomic compatibility with ASG device based on Gore Imaging Sciences review.\n\n   1. Treatment must be limited to the ascending aorta\n   2. Lesion location is ≥2cm distal to the most distal coronary artery ostia\n   3. Distal extent of the lesion is located ≥2cm proximal to the origin of the Brachiocephalic Artery (BCA)\n   4. Proximal and distal landing zones must be ≥2cm in length\n   5. Landing zones cannot be heavily calcified, or heavily thrombosed\n   6. Landing zone diameter between 27mm - 48mm\n   7. For patients with prior replacement of the ascending aorta and\u002For aortic arch by an endovascular or surgical graft, there must be at least ≥2 cm overlap of ASG device and previously implanted graft.\n3. Considered high-risk for open surgical repair by meeting any 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\u002For aortic arch surgeon (e.g., cardiothoracic surgeon).\n4. Age ≥18 years at time of informed consent signature\n5. Adequate vascular access via transfemoral or retroperitoneal approach\n6. Informed Consent Form (ICF) signed by the subject or legally authorized representative\n7. Agrees to comply with protocol requirements, including imaging and 5-year follow-up\n\nExclusion Criteria: ASG Device Alone Arm\n\nThe patient is\u002Fhas:\n\n1. De novo Type A dissection\n2. Requires immediate treatment\n3. Dissected great vessels requiring treatment\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) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment\n7. Open chest surgical repair within 30 days prior to treatment\n8. Presence of Intramural Hematoma (IMH) in landing zones\n9. Prosthetic heart valve in the aortic position that precludes safe delivery of the ASG device\n10. Aortic insufficiency grade 3 or greater\n11. Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair\n12. Concomitant vascular disease requiring treatment that is not planned for index endovascular procedure\n13. Any stroke or myocardial infarction within 6 weeks prior to treatment\n14. Presence of protruding and\u002For irregular thrombus and\u002For atheroma in the ascending aorta or aortic arch or any other factors that could increase the risk of stroke based on imaging review\n15. Known degenerative connective tissue disease (e.g., Marfan's or Ehler-Danlos Syndrome, EDS)\n16. Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor\n17. Known history of drug abuse within one year of treatment\n18. Pregnant at time of procedure\n19. Active infected aorta, mycotic aneurysm\n20. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication)\n21. Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) \\\u003C30 (mL\u002Fmin\u002F1.73 m2) or currently requiring dialysis\n22. Life expectancy \\\u003C12 months\n23. Known sensitivities or allergies to the device materials\n24. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment\n25. Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta\n\nInclusion Criteria: ASG + TBE Device Arm\n\nThe patient is\u002Fhas:\n\n1. Ascending and\u002For Arch Aortic pathologies warranting surgical repair compatible with the treatment requirements of the ASG device and meeting any of the following criteria: Aneurysms\n\n   1. Fusiform aneurysm (≥55 mm or documented growth rate \\>0.5cm\u002Fyear)\n   2. Saccular aneurysm (no diameter criteria)\n   3. Pseudoaneurysms (\\>30 days post-surgery, no diameter criteria) Non-aneurysms\n   4. Penetrating Aortic Ulcers (no diameter criteria)\n   5. Pseudoaneurysms, following open surgical repair of a Type A dissection (\\>30 days post-surgery, no diameter criteria)\n   6. Chronic de novo (\\>90 days) Type A aortic dissection requiring treatment\n\n      * Chronic de novo aortic dissection with primary entry tear in the ascending aorta or arch\n      * Chronic de novo aortic dissection with primary entry tear in the descending thoracic aorta with retrograde involvement of the aortic arch and\u002For ascending aorta\n   7. Residual aortic dissection following surgical repair of Type A aortic dissection requiring treatment (\\>30 days post-surgery)\n2. Anatomic compatibility with ASG device used in combination with the TBE Device based on Gore Imaging Sciences review.\n\n   Proximal Aortic Landing Zone:\n   1. Landing zone is native aorta or surgical graft\n   2. Lesion location is ≥2cm distal to the most distal coronary artery ostia\n   3. Proximal landing zone must be ≥2cm in the ascending aorta.\n   4. Landing zone cannot be aneurysmal, heavily calcified, or heavily thrombosed\n   5. Landing zone diameter between 27mm - 48mm\n   6. Acceptable proximal landing zone outer curvature length for the required device\n\n   Branch Vessel Landing Zone:\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 heavily thrombosed\n\n   Distal Aortic Landing Zone:\n   1. Outer curvature must be ≥2 cm proximal to the celiac artery\n   2. Aortic inner diameters between 16-42 mm\n   3. Landing zone in native aorta or previously implanted GORE® TAG® Conformable Thoracic Stent Graft (CTAG Device)\n3. Considered high-risk for open surgical repair by meeting any 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\u002For aortic arch surgeon (e.g., cardiothoracic surgeon).\n4. Age ≥18 years at time of informed consent signature\n5. Adequate vascular access via transfemoral or retroperitoneal approach\n6. Informed Consent Form (ICF) signed by the subject or legally authorized representative\n7. Agrees to comply with protocol requirements, including imaging and 5-year follow-up\n\nExclusion Criteria: ASG + TBE Device Arm\n\nThe patient is\u002Fhas:\n\n1. Acute and subacute de novo Type A dissection (defined as \\\u003C90 days)\n2. Requires immediate treatment\n3. Dissected great vessels requiring treatment\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) or treatment for acute coronary syndrome requiring Dual Anti Platelet Therapy (DAPT) within 30 days prior to treatment.\n7. Open chest surgical repair within 30 days prior to treatment\n8. Presence of Intramural Hematoma (IMH) in landing zones\n9. Prosthetic heart valve in the aortic position that precludes safe delivery of the ASG device\n10. Aortic insufficiency grade 3 or greater.\n11. Previous endovascular repair with a non-Gore device that would interfere with or result in contact with planned repair\n12. Concomitant vascular disease requiring treatment that is not planned for index endovascular procedure\n13. Any stroke or myocardial infarction within 6 weeks prior to treatment\n14. Presence of protruding and\u002For irregular thrombus and\u002For atheroma in the ascending aorta or aortic arch or any other factors that could increase the risk of stroke based on imaging review\n15. Known degenerative connective tissue disease (e.g., Marfan Syndrome or Ehlers-Danlos Syndrome, EDS)\n16. Participation in investigational drug or medical device study within one year of enrollment unless approved by the sponsor\n17. Known history of drug abuse within one year of treatment\n18. Pregnant at time of procedure\n19. Active infected aorta, mycotic aneurysm\n20. Active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication)\n21. Renal failure, defined as patients with an estimated Glomerular Filtration Rate (eGFR) \\\u003C30 (mL\u002Fmin\u002F1.73 m2) or currently requiring dialysis\n22. Life expectancy \\\u003C12 months\n23. Known sensitivities or allergies to the device materials\n24. Known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment\n25. Body habitus or other medical condition which prevents adequate fluoroscopic and CT visualization of the aorta\n26. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin or a history of a hypercoagulability disorder and\u002For state\n\nInclusion Criteria: Surgical Follow-up Cohort\n\nSubjects who meet the following criteria will be followed:\n\n1. The aortic lesion involves the ascending aorta and\u002For aortic arch\n2. The subject is determined to be high-risk for open surgical repair per the protocol requirements\n3. The subject is at least 18 years of age\n4. The subject is willing to comply with the protocol requirements\n5. Open surgery to repair the aortic lesion the patient was screened for is intended to be performed at the investigational site responsible for initiating the screening process for the study",[81,82],"ADULT","OLDER_ADULT",[84,93,101,108,112,119,127,135,143,151,158,166,174,182,190,198,206,213,221,229,237,245,253,260,267,275,282,290,298,305,312,320,328,335,342,350,358,365,373,381,389],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"University of Alabama at Birmingham","Birmingham","Alabama","35233","United States",{"lat":91,"lon":92},33.52066,-86.80249,{"facility":94,"city":95,"state":96,"zip":97,"country":89,"geoPoint":98},"MemorialCare Heart and Vascular Institute - Long Beach Medical Center","Long Beach","California","90806",{"lat":99,"lon":100},33.76696,-118.18923,{"facility":102,"city":103,"state":96,"zip":104,"country":89,"geoPoint":105},"Keck Medical Center University of Southern California, HCC II","Los Angeles","90033",{"lat":106,"lon":107},34.05223,-118.24368,{"facility":109,"city":103,"state":96,"zip":110,"country":89,"geoPoint":111},"Cedars Sinai Medical Center","90048",{"lat":106,"lon":107},{"facility":113,"city":114,"state":96,"zip":115,"country":89,"geoPoint":116},"Stanford Hospital","Stanford","94305",{"lat":117,"lon":118},37.42411,-122.16608,{"facility":120,"city":121,"state":122,"zip":123,"country":89,"geoPoint":124},"University of Colorado Hospital Authority","Aurora","Colorado","80045",{"lat":125,"lon":126},39.72943,-104.83192,{"facility":128,"city":129,"state":130,"zip":131,"country":89,"geoPoint":132},"Hartford Hospital","Hartford","Connecticut","06102",{"lat":133,"lon":134},41.76371,-72.68509,{"facility":136,"city":137,"state":138,"zip":139,"country":89,"geoPoint":140},"MedStar Washington Hospital Center","Washington D.C.","District of Columbia","20010",{"lat":141,"lon":142},38.89511,-77.03637,{"facility":144,"city":145,"state":146,"zip":147,"country":89,"geoPoint":148},"University of Florida - Gainesville","Gainesville","Florida","32610",{"lat":149,"lon":150},29.65163,-82.32483,{"facility":152,"city":153,"state":146,"zip":154,"country":89,"geoPoint":155},"University of South Florida","Tampa","33606",{"lat":156,"lon":157},27.94752,-82.45843,{"facility":159,"city":160,"state":161,"zip":162,"country":89,"geoPoint":163},"Emory University Hospital","Atlanta","Georgia","30322",{"lat":164,"lon":165},33.749,-84.38798,{"facility":167,"city":168,"state":169,"zip":170,"country":89,"geoPoint":171},"Northwestern University -Bluhm Cardiovascular Institute, Clinical Trials Unit","Chicago","Illinois","60611",{"lat":172,"lon":173},41.85003,-87.65005,{"facility":175,"city":176,"state":177,"zip":178,"country":89,"geoPoint":179},"Indiana University School of Medicine","Indianapolis","Indiana","46202",{"lat":180,"lon":181},39.76838,-86.15804,{"facility":183,"city":184,"state":185,"zip":186,"country":89,"geoPoint":187},"University of Maryland Medical Center","Baltimore","Maryland","21201",{"lat":188,"lon":189},39.29038,-76.61219,{"facility":191,"city":192,"state":193,"zip":194,"country":89,"geoPoint":195},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":196,"lon":197},42.35843,-71.05977,{"facility":199,"city":200,"state":201,"zip":202,"country":89,"geoPoint":203},"University of Michigan Frankel Cardiovascular Center","Ann Arbor","Michigan","48109",{"lat":204,"lon":205},42.27756,-83.74088,{"facility":207,"city":208,"state":201,"zip":209,"country":89,"geoPoint":210},"Corewell Health","Grand Rapids","49503",{"lat":211,"lon":212},42.96336,-85.66809,{"facility":214,"city":215,"state":216,"zip":217,"country":89,"geoPoint":218},"Mayo Clinic - Rochester","Rochester","Minnesota","55905",{"lat":219,"lon":220},44.02163,-92.4699,{"facility":222,"city":223,"state":224,"zip":225,"country":89,"geoPoint":226},"Washington University School of Medicine - St. Louis","St Louis","Missouri","63110",{"lat":227,"lon":228},38.62727,-90.19789,{"facility":230,"city":231,"state":232,"zip":233,"country":89,"geoPoint":234},"Hackensack UMC","Hackensack","New Jersey","07601",{"lat":235,"lon":236},40.88593,-74.04347,{"facility":238,"city":239,"state":240,"zip":241,"country":89,"geoPoint":242},"Westchester Medical Center","Valhalla","New York","10595",{"lat":243,"lon":244},41.07482,-73.77513,{"facility":246,"city":247,"state":248,"zip":249,"country":89,"geoPoint":250},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"lat":251,"lon":252},35.9132,-79.05584,{"facility":254,"city":255,"state":248,"zip":256,"country":89,"geoPoint":257},"Atrium Health","Charlotte","28204",{"lat":258,"lon":259},35.22709,-80.84313,{"facility":261,"city":262,"state":248,"zip":263,"country":89,"geoPoint":264},"Duke University Medical Center","Durham","27710",{"lat":265,"lon":266},35.99403,-78.89862,{"facility":268,"city":269,"state":270,"zip":271,"country":89,"geoPoint":272},"Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"lat":273,"lon":274},41.4995,-81.69541,{"facility":276,"city":277,"state":270,"zip":278,"country":89,"geoPoint":279},"OhioHealth Research and Innovation Institute","Columbus","43214",{"lat":280,"lon":281},39.96118,-82.99879,{"facility":283,"city":284,"state":285,"zip":286,"country":89,"geoPoint":287},"Oregon Health and Science University","Portland","Oregon","97239",{"lat":288,"lon":289},45.52345,-122.67621,{"facility":291,"city":292,"state":293,"zip":294,"country":89,"geoPoint":295},"University of Pennsylvania","Philadelphia","Pennsylvania","19105",{"lat":296,"lon":297},39.95238,-75.16362,{"facility":299,"city":300,"state":293,"zip":301,"country":89,"geoPoint":302},"University of Pittsburgh Medical Center","Pittsburgh","15232",{"lat":303,"lon":304},40.44062,-79.99589,{"facility":306,"city":307,"state":293,"zip":308,"country":89,"geoPoint":309},"Lankenau Institute for Medical Research","Wynnewood","19096",{"lat":310,"lon":311},40.00289,-75.27074,{"facility":313,"city":314,"state":315,"zip":316,"country":89,"geoPoint":317},"Medical University of South Carolina","Charleston","South Carolina","29425",{"lat":318,"lon":319},32.77632,-79.93275,{"facility":321,"city":322,"state":323,"zip":324,"country":89,"geoPoint":325},"Cardiothoracic and Vascular Surgeons","Austin","Texas","78756",{"lat":326,"lon":327},30.26715,-97.74306,{"facility":329,"city":330,"state":323,"zip":331,"country":89,"geoPoint":332},"Methodist DeBakey Heart & Vascular Center","Houston","77030",{"lat":333,"lon":334},29.76328,-95.36327,{"facility":336,"city":337,"state":323,"zip":338,"country":89,"geoPoint":339},"The Heart Hospital at Baylor Plano","Plano","75093",{"lat":340,"lon":341},33.01984,-96.69889,{"facility":343,"city":344,"state":345,"zip":346,"country":89,"geoPoint":347},"Intermountain Heart Institute","Murray","Utah","84107",{"lat":348,"lon":349},40.66689,-111.88799,{"facility":351,"city":352,"state":353,"zip":354,"country":89,"geoPoint":355},"Inova Fairfax Medical Campus","Falls Church","Virginia","22042",{"lat":356,"lon":357},38.88233,-77.17109,{"facility":359,"city":360,"state":353,"zip":361,"country":89,"geoPoint":362},"Sentara Mid Atlantic Cardiothoracic Surgeons","Norfolk","23507",{"lat":363,"lon":364},36.84681,-76.28522,{"facility":366,"city":367,"state":368,"zip":369,"country":89,"geoPoint":370},"University of Washington Medical Center","Seattle","Washington","98195",{"lat":371,"lon":372},47.60621,-122.33207,{"facility":374,"city":375,"state":376,"zip":377,"country":89,"geoPoint":378},"West Virginia University Medicine","Morgantown","West Virginia","26506",{"lat":379,"lon":380},39.62953,-79.9559,{"facility":382,"city":383,"state":384,"zip":385,"country":89,"geoPoint":386},"University of Wisconsin Hospital & Clinics","Madison","Wisconsin","53792",{"lat":387,"lon":388},43.07305,-89.40123,{"facility":390,"city":391,"state":384,"zip":392,"country":89,"geoPoint":393},"Medical College of Wisconsin","Milwaukee","53226",{"lat":394,"lon":395},43.0389,-87.90647,[],[398],{"name":399,"affiliation":400,"role":401},"Eric Roselli, MD","The Cleveland Clinic","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":405,"biomarkers":410},[406,21,25,407,408,409],"Aortic Aneurysm","Aortic Pseudoaneurysm","Intramural hematoma","Penetrating Atherosclerotic Ulcer",[],{"nct_id":4,"found":73,"summary":17,"prompt_version":17}]