[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06687590":3,"trial-entities:NCT06687590":338,"trial-summary:NCT06687590":344},{"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":22,"study_type":23,"primary_purpose":17,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":35,"secondary_outcomes":40,"sex":44,"minimum_age":45,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":46,"std_ages":56,"locations":59,"central_contacts":330,"overall_officials":335,"references":336,"see_also_links":337},"NCT06687590","CSP-0696","Serranator POINT FORCE Registry","POst-Market ClINical Follow-up STudy oF the SerranatOR PTA Serration Balloon CathEter","RECRUITING","2026-08-31","2026-05","2026-05-07","2025-01-22","Cagent Vascular LLC","INDUSTRY",false,"The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® in treatment of peripheral artery disease (PAD), or dysfunctional native or synthetic arteriovenous dialysis fistulae in a real-world scenario.\n\nThe data and conclusions derived from this study will be used to provide clinical evidence for the clinical evaluation process.",null,[19,20,21],"Peripheral Artery Disease (PAD)","Dysfunctional AV Fistula","Dysfunctional AV Graft",[],"OBSERVATIONAL",[],{"count":26,"type":27},500,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DEVICE","Peripheral balloon angioplasty","Serration balloon angioplasty of iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries, or dysfunctional native or synthetic arteriovenous dialysis fistula",[34],"Subjects",[36],{"measure":37,"description":38,"timeFrame":39},"Performance Endpoint","Device Success defined as the achievement of successful delivery, balloon inflation and deflation, and retrieval of the study device(s) with a post- Serranator® residual stenosis of ≤30% by angiographic core laboratory assessment at the intended target lesion.","Peri-procedural",[41],{"measure":42,"description":43,"timeFrame":39},"Safety Endpoint","Major Adverse Events (MAE) until discharge, defined as all amputations and any re-intervention (surgical or endovascular) in the target limb.","ALL","18 Years",{"inclusion":47,"exclusion":52,"raw_text":55},[48,49,50,51],"Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.","Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.","Age of subject is \\> 18.","Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.",[53,54],"Subjects with any medical condition that would make him\u002Fher an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.","Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.","Inclusion Criteria:\n\n* Subjects intended to be treated with Serranator® for de-novo or restenotic lesions of the iliac, femoral, iliofemoral, popliteal, infrapopliteal and pedal arteries or dysfunctional native or synthetic arteriovenous dialysis fistulae.\n* Subjects presenting with claudication or critical limb-threatening ischemia (CLTI) by Rutherford Clinical Category 3, 4, 5, or 6 of the target limb.\n* Age of subject is \\> 18.\n* Subject or subject's legal representative has been informed of the nature of the study, agrees to participate and has signed the approved consent form.\n\nExclusion Criteria:\n\n* Subjects with any medical condition that would make him\u002Fher an inappropriate candidate for treatment with Serranator® as per Instructions for Use (IFU) or investigator's opinion.\n* Subject already enrolled in other investigational (interventional) studies that would interfere with study endpoints.",[57,58],"ADULT","OLDER_ADULT",[60,77,91,105,122,137,151,166,179,197,213,226,239,253,268,277,288,302,317],{"facility":61,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":74},"HonorHealth","Scottsdale","Arizona","85251","United States",[67,71],{"name":68,"role":69,"email":70},"Ayda Aliyari","CONTACT","ayda.aliyari@honorhealth.com",{"name":72,"role":73},"Mitri Khoury, MD","PRINCIPAL_INVESTIGATOR",{"lat":75,"lon":76},33.50921,-111.89903,{"facility":78,"status":8,"city":79,"state":80,"zip":81,"country":65,"contacts":82,"geoPoint":88},"Cedars-Sinai Medical Center","Los Angeles","California","90048",[83,86],{"name":68,"role":69,"phone":84,"email":85},"(310) 248-7465","ayda.aliyari@cshs.org",{"name":87,"role":73},"Donald Baril",{"lat":89,"lon":90},34.05223,-118.24368,{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":65,"contacts":96,"geoPoint":102},"Hartford HealthCare","Hartford","Connecticut","06102",[97,100],{"name":98,"role":69,"email":99},"Candace Johnson","candace.johnson@hhchealth.org",{"name":101,"role":73},"Edward Gifford, MD",{"lat":103,"lon":104},41.76371,-72.68509,{"facility":106,"status":8,"city":107,"state":108,"zip":109,"country":65,"contacts":110,"geoPoint":119},"MedStar Washington Hospital \u002F MedStar Montgomery","Washington D.C.","District of Columbia","20010",[111,115,117],{"name":112,"role":69,"phone":113,"email":114},"Kassaye Sesaba","202-877-8475","kassaye.s.sesaba@medstar.net",{"name":116,"role":73},"Nelson Bernardo, MD",{"name":118,"role":73},"Kyle B Reynolds, MD",{"lat":120,"lon":121},38.89511,-77.03637,{"facility":123,"status":8,"city":124,"state":125,"zip":126,"country":65,"contacts":127,"geoPoint":134},"Manatee Memorial","Bradenton","Florida","34208",[128,132],{"name":129,"role":69,"phone":130,"email":131},"Camila Vera","(941) 746-5111","camila.vera@novaclinicalresearch.com",{"name":133,"role":73},"S. Jay Mathews, MD",{"lat":135,"lon":136},27.49893,-82.57482,{"facility":138,"status":8,"city":139,"state":125,"zip":140,"country":65,"contacts":141,"geoPoint":148},"Radiology and Imaging Specialists","Lakeland","33801",[142,146],{"name":143,"role":69,"phone":144,"email":145},"Eve Johnson","352-284-7642","ejohnson@risimaging.com",{"name":147,"role":73},"Michael Campbell",{"lat":149,"lon":150},28.03947,-81.9498,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":65,"contacts":156,"geoPoint":163},"Henry Ford Health","Detroit","Michigan","48202",[157,161],{"name":158,"role":69,"phone":159,"email":160},"Renee Bess","(313) 916-2600","rbess1@hfhs.org",{"name":162,"role":73},"Thomas Davis, MD",{"lat":164,"lon":165},42.33143,-83.04575,{"facility":167,"status":8,"city":168,"state":169,"zip":170,"country":65,"contacts":171,"geoPoint":176},"Barnes Jewish","St Louis","Missouri","63141",[172,174],{"name":173,"role":69},"Kelly Koogler",{"name":175,"role":73},"Vipul Khetarpaul, MD",{"lat":177,"lon":178},38.62727,-90.19789,{"facility":180,"status":8,"city":181,"state":182,"zip":183,"country":65,"contacts":184,"geoPoint":194},"Atlantic Medical Imaging","Brick","New Jersey","08724",[185,189,191],{"name":186,"role":69,"phone":187,"phoneExt":188},"Melisa Rivera","856-362-6056","3571",{"name":190,"role":73},"Nicholas Petruzzi",{"name":192,"role":193},"Micah Watts","SUB_INVESTIGATOR",{"lat":195,"lon":196},40.05928,-74.13708,{"facility":198,"status":8,"city":199,"state":182,"zip":200,"country":65,"contacts":201,"geoPoint":210},"Virtua Health","Marlton","08053",[202,206,208],{"name":203,"role":69,"phone":204,"email":205},"Jocelyn Bordelon","856-355-1225","jbordelo@virtua.org",{"name":207,"role":73},"Luai Tabaza",{"name":209,"role":193},"Anthony Smeglin, MD",{"lat":211,"lon":212},39.89122,-74.92183,{"facility":214,"status":8,"city":215,"state":216,"zip":217,"country":65,"contacts":218,"geoPoint":223},"Northwell","New Hyde Park","New York","11042",[219],{"name":220,"role":69,"phone":221,"email":222},"Victoria Waimiru","(516) 865 - 8800","mwaimiru@northwell.edu",{"lat":224,"lon":225},40.7351,-73.68791,{"facility":227,"status":8,"city":228,"state":229,"zip":230,"country":65,"contacts":231,"geoPoint":236},"Ohio State University Medical Center","Columbus","Ohio","43210",[232],{"name":233,"role":69,"phone":234,"email":235},"Subhashish Das","614-366-6596","subhashish.das@osumc.edu",{"lat":237,"lon":238},39.96118,-82.99879,{"facility":240,"status":8,"city":241,"state":229,"zip":242,"country":65,"contacts":243,"geoPoint":250},"Miami Valley Hospital","Dayton","45409",[244,248],{"name":245,"role":69,"phone":246,"email":247},"Heather Bell","937-208-6013","hbell@premierhealth.com",{"name":249,"role":73},"Sagger Mawri",{"lat":251,"lon":252},39.75895,-84.19161,{"facility":254,"status":8,"city":255,"state":256,"zip":257,"country":65,"contacts":258,"geoPoint":265},"Oregon Health & Sciences University","Portland","Oregon","97239",[259,263],{"name":260,"role":69,"phone":261,"email":262},"Amie Lorisch","971-349-6659","lorischa@ohsu.edu",{"name":264,"role":73},"Rhusheet Patel",{"lat":266,"lon":267},45.52345,-122.67621,{"facility":269,"status":270,"city":271,"state":272,"zip":273,"country":65,"geoPoint":274},"Penn Presbyterian Medical Center","ACTIVE_NOT_RECRUITING","Philadelphia","Pennsylvania","19104",{"lat":275,"lon":276},39.95238,-75.16362,{"facility":278,"status":8,"city":271,"state":272,"zip":279,"country":65,"contacts":280,"geoPoint":287},"Jefferson Einstein","19141",[281,285],{"name":282,"role":69,"phone":283,"email":284},"Vibha Ahuja","215-456-7231","vibha.ahuja@jefferson.edu",{"name":286,"role":73},"Sahil Banka",{"lat":275,"lon":276},{"facility":289,"status":8,"city":290,"state":291,"zip":292,"country":65,"contacts":293,"geoPoint":299},"Brown Health","Providence","Rhode Island","02912",[294,297],{"name":295,"role":69,"phone":296},"Bailey Nevins","401-793-4105",{"name":298,"role":73},"Peter Soukas, MD",{"lat":300,"lon":301},41.82399,-71.41283,{"facility":303,"status":8,"city":304,"state":305,"zip":306,"country":65,"contacts":307,"geoPoint":314},"Prisma Health","Greenville","South Carolina","29615",[308,312],{"name":309,"role":69,"phone":310,"email":311},"Nikita Kasinger","864-454-2818","nikita.kasinger@prismahealth.org",{"name":313,"role":73},"Sagar Gandhi",{"lat":315,"lon":316},34.85262,-82.39401,{"facility":318,"status":8,"city":319,"state":320,"zip":321,"country":65,"contacts":322,"geoPoint":327},"Aurora St. Luke's","Milwaukee","Wisconsin","53215",[323,325],{"name":324,"role":69},"Reva Matz",{"name":326,"role":73},"Mark Mewissen, MD",{"lat":328,"lon":329},43.0389,-87.90647,[331],{"name":332,"role":69,"phone":333,"email":334},"Alexis Shewfelt","6502086743","ashewfelt33@cagentvascular.com",[],[],[],{"nct_id":4,"conditions":339,"biomarkers":343},[340,341,342],"Arteriovenous Fistula","Arteriovenous graft","Peripheral Artery Disease",[],{"nct_id":4,"found":345,"summary":346,"prompt_version":356},true,{"design":347,"status":348,"heading":349,"summary":350,"follow_up":351,"word_count":352,"commitments":353,"compensation":354,"drugs_mentioned":355},"This is an observational study that aims to enroll 500 participants. It collects data under standard medical care.","completed","Serranator POINT FORCE Registry for PAD and Dysfunctional AV Fistulas\u002FGrafts","This study is a registry, meaning it collects information about how the Serranator® device works in real-world situations. It's for people with Peripheral Artery Disease (PAD), which affects blood flow to your limbs, or those with a dysfunctional (not working well) AV fistula or graft, which are used for dialysis. The study will look at the safety and performance of the Serranator® when used to treat blockages in arteries or problems with dialysis access. To join, you must be 18 or older and your doctor plans to treat you with the Serranator® for these conditions. The main goal is to see how well the device performs right after the procedure. The current recruitment status is unclear.","The primary performance endpoint is measured around the time of the procedure (peri-procedural).",116,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]