[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06029660":3,"trial-entities:NCT06029660":425,"trial-summary:NCT06029660":428},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":43,"secondary_outcomes":52,"sex":53,"minimum_age":54,"maximum_age":16,"healthy_volunteers":55,"eligibility_criteria":56,"std_ages":60,"locations":63,"central_contacts":418,"overall_officials":419,"references":423,"see_also_links":424},"NCT06029660","CRD 1029","AAA-SHAPE Pivotal Trial: Abdominal Aortic Aneurysm Sac Healing and Prevention of Expansion","ACTIVE_NOT_RECRUITING","2031-07","2026-07","2026-07-10","2024-04-05","Shape Memory Medical, Inc.","INDUSTRY",true,"To determine the safety and effectiveness of IMPEDE-FX RapidFill to increase the percentage of subjects with shrinkage of the abdominal aortic aneurysm sac when used as an adjunct to on-label endovascular aneurysm repair (EVAR) stent graft treatment in trial subjects considered candidates for elective EVAR.",null,[18],"Aortic Aneurysm, Abdominal",[20],"Abdominal Aortic Aneurysm","INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},180,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","IMPEDE-FX RapidFill Implants","Filling of the available flow lumen within the AAA sac with IMPEDE-FX RapidFill Implants",[34],"Treatment",{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"PROCEDURE","EndoVascular Aneurysm Repair","Standard EVAR repair of abdominal aortic aneurysms using a commercially available stent.",[40,34],"Control",[42],"EVAR",[44,48],{"measure":45,"description":46,"timeFrame":47},"Primary Effectiveness Endpoint : AAA Sac Regression at 1 year","The percentage of subjects showing regression, defined as sac volume reduction of ≥10% at 1 year (in comparison to the 30 day CT), and no AAA-related intervention through 1 year.","1 year",{"measure":49,"description":50,"timeFrame":51},"Primary Safety Endpoint : Major Adverse Event (MAE) Rate through 30 days","Freedom from the following through 30 days post-index procedure:\n\n* Major adverse events (MAEs) which include the following: all-cause mortality, bowel ischemia, myocardial infarction, paraplegia, renal failure, respiratory failure, stroke, procedural blood loss \\>1000 mL.\n* AAA-rupture or AAA-perforation\n* Conversion to Open Repair","30 days",[],"ALL","18 Years",false,{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Inclusion Criteria:\n\n1. ≥18 years of age\n2. A candidate for elective EVAR of an infrarenal fusiform aortic aneurysm ≥5.5 cm in diameter in men and ≥5.0 cm in women;\n3. Thrombus burden (percentage of the AAA sac occupied by thrombus) \\\u003C50%, based on pre-procedure CTA\n4. Maximum Lumen diameter within the AAA sac of ≥40mm.\n5. The predicted minimum number of IMPEDE-FX RapidFill Implants for the subject is ≤200.\n\nExclusion Criteria:\n\nGeneral\n\n1. An inability to provide informed consent.\n2. Enrolled in another clinical study that could interfere with the outcomes being studied in this trial.\n3. Unable or unwilling to comply with study follow-up requirements.\n4. Prisoner or member of other vulnerable population\n\nAnatomical\n\n1. Concomitant iliac artery ectasia or aneurysm\n2. Vascular disease and\u002For anatomy that preclude the safe access and positioning of a catheter to deliver the investigational product into the AAA sac.\n3. Ruptured, leaking, inflammatory or mycotic (infected) aneurysm.\n4. Connective tissue disorder (e.g., Marfan's syndrome)\n5. Aneurysmal disease of the descending thoracic aorta\n6. Excessive calcification at the aortic bifurcation to common\u002Finternal iliac bifurcation, that might lead to access difficulties\n\nEVAR\u002FProcedural\n\n1. Use of aortic stent grafts other than the Gore Excluder AAA Endoprosthesis, Gore Excluder Conformable AAA Endoprosthesis, Cook Zenith Flex AAA Endovascular Graft, Medtronic Endurant II and Endurant IIs Stent Graft, or the Terumo TREO Stent Graft to treat the AAA\n2. Use of an aortic stent graft other than those specified1 for a particular site\n3. Planned use of the chosen stent graft outside its instructions for use (IFU)\n4. Use of fenestrated stent grafts or chimney techniques\n5. Use of the Heli-FX EndoAnchor system\n6. Use of embolic devices other than the investigational product to embolize the AAA sac\n7. Use of embolic products to prophylactically or concomitantly embolize the inferior mesenteric artery, lumbar arteries, renal accessory arteries, or internal iliac arteries\n8. Inability to land the distal-most portion of the EVAR stent graft limbs, including extensions, above the internal iliac arteries\n\nMedical History\u002FConditions\n\n1. Coagulopathy or uncontrolled bleeding disorder\n2. Serum creatinine level \\>2.5 mg\u002FdL\n3. Cerebrovascular accident within 3 months prior to the procedure\n4. Myocardial infarction and\u002For major heart surgery within 3 months prior to the procedure\n5. Atrial fibrillation that is not well rate controlled\n6. Life expectancy of \\\u003C2 years post-procedure\n7. Known hypersensitivity or contraindication to platinum, iridium, or polyurethane.\n8. Have active infection at the time of the index procedure documented by pain, fever, drainage, positive culture, or leukocytosis (WBC \\>11,000\u002Fmm3)\n9. A condition that inhibits radiographic visualization during the implantation procedure\n10. History of allergy to contrast medium that cannot be managed medically, or subject is unable to have a CT with contrast for any reason.\n11. Uncontrolled co-morbid medical condition, including mental health issues, that would adversely affect participation in the trial\n12. Pregnant or lactating female: for females of child-bearing potential, based on a positive pregnancy test within 7 days prior to the procedure or refusal to use a medically accepted method of birth control for the duration of the trial",[61,62],"ADULT","OLDER_ADULT",[64,73,81,89,96,104,111,118,125,133,141,149,157,165,173,177,181,189,196,204,212,220,224,230,234,240,247,255,262,270,278,286,294,301,308,315,323,330,337,345,354,362,371,378,384,391,399,406,414],{"facility":65,"city":66,"state":67,"zip":68,"country":69,"geoPoint":70},"University of Alabama Birmingham","Birmingham","Alabama","35233","United States",{"lat":71,"lon":72},33.52066,-86.80249,{"facility":74,"city":75,"state":76,"zip":77,"country":69,"geoPoint":78},"Honor Health","Scottsdale","Arizona","85258",{"lat":79,"lon":80},33.50921,-111.89903,{"facility":82,"city":83,"state":84,"zip":85,"country":69,"geoPoint":86},"USC Keck","Los Angeles","California","90033",{"lat":87,"lon":88},34.05223,-118.24368,{"facility":90,"city":91,"state":84,"zip":92,"country":69,"geoPoint":93},"San Diego VA Medical Center","San Diego","92161",{"lat":94,"lon":95},32.71571,-117.16472,{"facility":97,"city":98,"state":99,"zip":100,"country":69,"geoPoint":101},"Delray Medical Center","Delray Beach","Florida","33484",{"lat":102,"lon":103},26.46146,-80.07282,{"facility":105,"city":106,"state":99,"zip":107,"country":69,"geoPoint":108},"Mt. Sinai Medical Center","Miami Beach","33140",{"lat":109,"lon":110},25.79065,-80.13005,{"facility":112,"city":113,"state":99,"zip":114,"country":69,"geoPoint":115},"Orlando Health","Orlando","32806",{"lat":116,"lon":117},28.53834,-81.37924,{"facility":119,"city":120,"state":99,"zip":121,"country":69,"geoPoint":122},"University of South Florida","Tampa","33606",{"lat":123,"lon":124},27.94752,-82.45843,{"facility":126,"city":127,"state":128,"zip":129,"country":69,"geoPoint":130},"Emory University Hospital","Atlanta","Georgia","30322",{"lat":131,"lon":132},33.749,-84.38798,{"facility":134,"city":135,"state":136,"zip":137,"country":69,"geoPoint":138},"University of Chicago","Chicago","Illinois","60637",{"lat":139,"lon":140},41.85003,-87.65005,{"facility":142,"city":143,"state":144,"zip":145,"country":69,"geoPoint":146},"Indiana University","Indianapolis","Indiana","46202",{"lat":147,"lon":148},39.76838,-86.15804,{"facility":150,"city":151,"state":152,"zip":153,"country":69,"geoPoint":154},"Maine Medical","Portland","Maine","04102",{"lat":155,"lon":156},43.65737,-70.2589,{"facility":158,"city":159,"state":160,"zip":161,"country":69,"geoPoint":162},"Johns Hopkins","Baltimore","Maryland","21205",{"lat":163,"lon":164},39.29038,-76.61219,{"facility":166,"city":167,"state":168,"zip":169,"country":69,"geoPoint":170},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":171,"lon":172},42.35843,-71.05977,{"facility":174,"city":167,"state":168,"zip":175,"country":69,"geoPoint":176},"Brigham & Women's Hospital","02115",{"lat":171,"lon":172},{"facility":178,"city":167,"state":168,"zip":179,"country":69,"geoPoint":180},"Beth Israel Deaconess Medical Center","02215",{"lat":171,"lon":172},{"facility":182,"city":183,"state":184,"zip":185,"country":69,"geoPoint":186},"VA Ann Arbor Healthcare","Ann Arbor","Michigan","48105",{"lat":187,"lon":188},42.27756,-83.74088,{"facility":190,"city":191,"state":184,"zip":192,"country":69,"geoPoint":193},"Corewell Health","Grand Rapids","49503",{"lat":194,"lon":195},42.96336,-85.66809,{"facility":197,"city":198,"state":199,"zip":200,"country":69,"geoPoint":201},"Mayo Clinic","Rochester","Minnesota","55902",{"lat":202,"lon":203},44.02163,-92.4699,{"facility":205,"city":206,"state":207,"zip":208,"country":69,"geoPoint":209},"Dartmouth Hitchcock Medical Center","Lebanon","New Hampshire","03756",{"lat":210,"lon":211},43.64229,-72.25176,{"facility":213,"city":214,"state":215,"zip":216,"country":69,"geoPoint":217},"University at Buffalo","Buffalo","New York","14203",{"lat":218,"lon":219},42.88645,-78.87837,{"facility":221,"city":214,"state":215,"zip":222,"country":69,"geoPoint":223},"Buffalo VA Western New York","14215",{"lat":218,"lon":219},{"facility":225,"city":215,"state":215,"zip":226,"country":69,"geoPoint":227},"NYU Langone","10016",{"lat":228,"lon":229},40.71427,-74.00597,{"facility":231,"city":215,"state":215,"zip":232,"country":69,"geoPoint":233},"Columbia University Irving Medical Center\u002FNew York Presbyterian Hospital","10032",{"lat":228,"lon":229},{"facility":235,"city":198,"state":215,"zip":236,"country":69,"geoPoint":237},"University of Rochester","14642",{"lat":238,"lon":239},43.15478,-77.61556,{"facility":241,"city":242,"state":215,"zip":243,"country":69,"geoPoint":244},"Stony Brook Medicine","Stony Brook","11794",{"lat":245,"lon":246},40.92565,-73.14094,{"facility":248,"city":249,"state":250,"zip":251,"country":69,"geoPoint":252},"TriHealth Heart Institute","Cincinnati","Ohio","45242",{"lat":253,"lon":254},39.12711,-84.51439,{"facility":256,"city":257,"state":250,"zip":258,"country":69,"geoPoint":259},"Ohio State University Wexner Medical Center","Columbus","43210",{"lat":260,"lon":261},39.96118,-82.99879,{"facility":263,"city":264,"state":265,"zip":266,"country":69,"geoPoint":267},"The Hospital of the University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"lat":268,"lon":269},39.95238,-75.16362,{"facility":271,"city":272,"state":273,"zip":274,"country":69,"geoPoint":275},"Sanford Health","Sioux Falls","South Dakota","57105",{"lat":276,"lon":277},43.54369,-96.72796,{"facility":279,"city":280,"state":281,"zip":282,"country":69,"geoPoint":283},"Vanderbilt University","Nashville","Tennessee","37232",{"lat":284,"lon":285},36.16589,-86.78444,{"facility":287,"city":288,"state":289,"zip":290,"country":69,"geoPoint":291},"St. David's Healthcare","Austin","Texas","78705",{"lat":292,"lon":293},30.26715,-97.74306,{"facility":295,"city":296,"state":289,"zip":297,"country":69,"geoPoint":298},"Houston Methodist","Houston","77030",{"lat":299,"lon":300},29.76328,-95.36327,{"facility":302,"city":303,"state":289,"zip":304,"country":69,"geoPoint":305},"Baylor Scott and White","Plano","75093",{"lat":306,"lon":307},33.01984,-96.69889,{"facility":309,"city":310,"state":289,"zip":311,"country":69,"geoPoint":312},"The University of Texas Health Science Center at San Antonio","San Antonio","78229",{"lat":313,"lon":314},29.42412,-98.49363,{"facility":316,"city":317,"state":318,"zip":319,"country":69,"geoPoint":320},"University of Virginia","Charlottesville","Virginia","22903",{"lat":321,"lon":322},38.02931,-78.47668,{"facility":324,"city":325,"state":318,"zip":326,"country":69,"geoPoint":327},"Inova Schar Heart and Vascular","Falls Church","22042",{"lat":328,"lon":329},38.88233,-77.17109,{"facility":331,"city":332,"state":318,"zip":333,"country":69,"geoPoint":334},"Sentara Norfolk General","Norfolk","23507",{"lat":335,"lon":336},36.84681,-76.28522,{"facility":338,"city":339,"state":340,"zip":341,"country":69,"geoPoint":342},"University of Wisconsin","Madison","Wisconsin","53715",{"lat":343,"lon":344},43.07305,-89.40123,{"facility":346,"city":347,"state":348,"zip":349,"country":350,"geoPoint":351},"Hopital Cardiologie","Lille","Hauts-de-France","59037","France",{"lat":352,"lon":353},50.63391,3.05512,{"facility":355,"city":356,"state":357,"zip":358,"country":350,"geoPoint":359},"Marie Lannelongue Hospital","Paris","Le Plessis-Robinson","92350,",{"lat":360,"lon":361},48.85341,2.3488,{"facility":363,"city":364,"state":365,"zip":366,"country":367,"geoPoint":368},"Rijnstate Hospital","Arnhem","Gelderland","6800 TA","Netherlands",{"lat":369,"lon":370},51.98,5.91111,{"facility":372,"city":373,"state":373,"zip":374,"country":367,"geoPoint":375},"ETZ Elisabeth","Tilburg","5022 GC",{"lat":376,"lon":377},51.55551,5.0913,{"facility":379,"city":380,"country":367,"geoPoint":381},"Amsterdam UMC","Amsterdam",{"lat":382,"lon":383},52.37403,4.88969,{"facility":385,"city":386,"zip":387,"country":367,"geoPoint":388},"Erasmus Medical Center","Rotterdam","3015 GD",{"lat":389,"lon":390},51.9225,4.47917,{"facility":392,"city":393,"state":393,"zip":394,"country":395,"geoPoint":396},"Auckland City Hospital","Auckland","1023","New Zealand",{"lat":397,"lon":398},-36.84853,174.76349,{"facility":400,"city":401,"zip":402,"country":395,"geoPoint":403},"Waikato Hospital","Hamilton","3204",{"lat":404,"lon":405},-37.78333,175.28333,{"facility":407,"city":408,"zip":409,"country":410,"geoPoint":411},"St Georges University Hospitals NHS Foundation Trust","London","SW17 0GT","United Kingdom",{"lat":412,"lon":413},51.50853,-0.12574,{"facility":415,"city":408,"zip":416,"country":410,"geoPoint":417},"St. Marys Hospital","W21 1NY",{"lat":412,"lon":413},[],[420],{"name":421,"affiliation":178,"role":422},"Marc Schermerhorn, M.D.","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":426,"biomarkers":427},[20],[],{"nct_id":4,"found":55,"summary":16,"prompt_version":16}]