[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04077762":3,"trial-entities:NCT04077762":222,"trial-summary:NCT04077762":226},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":43,"secondary_outcomes":47,"sex":90,"minimum_age":91,"maximum_age":17,"healthy_volunteers":92,"eligibility_criteria":93,"std_ages":113,"locations":116,"central_contacts":208,"overall_officials":213,"references":216,"see_also_links":221},"NCT04077762","REBIRTH","Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access Site Complication Reduction in Cardiac Catheterization (REBIRTH)","Radial vs. State-Of-The-Art Femoral Access for Bleeding and Access SIte Complication Reduction in Cardiac Catheterization (REBIRTH)","RECRUITING","2028-08-19","2026-08","2026-08-19","2019-11-15","Minneapolis Heart Institute Foundation","OTHER",true,"This is a phase IV, prospective, open label, randomized-controlled study that will compare radial access with state-of-the-art femoral access in patients without ST-segment elevation acute myocardial infarction undergoing cardiac catheterization. Subjects will be randomized 1:1 into 2 treatment groups: radial access and state-of-the-art femoral access. Randomization will be performed in blocks of 50 per site. Similarly, a second sub-randomization will be performed in the femoral access group into use of 18 vs 21 gauge needles, also in a 1:1 fashion.",null,[19,20],"Patient Satisfaction","Vascular Access Complication",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},3266,"ESTIMATED",[30,35,39],{"type":31,"name":32,"description":32,"armGroupLabels":33},"PROCEDURE","Radial Access",[34],"Radial access",{"type":31,"name":36,"description":36,"armGroupLabels":37},"State-of-the-art femoral access with 18 gauge needle",[38],"State-of-the-art femoral access",{"type":31,"name":40,"description":41,"armGroupLabels":42},"State-of-the-art femoral access with 21 gauge needle","State-of-the-art femoral access with 21 gauge needle. For patients randomized to micropuncture (21G) the micropuncture wire must be advanced under fluoroscopy to avoid inadvertent wiring of side-branches.",[38],[44],{"measure":45,"timeFrame":46},"Incidence of the composite of vascular access complications and bleeding (BARC 2, 3, or 5)","Evaluations will occur up to 30 days",[48,50,52,54,58,60,63,66,68,71,73,75,78,80,82,85,87],{"measure":49,"timeFrame":46},"Total number of BARC type 2, 3, or 5 bleeding events",{"measure":51,"timeFrame":46},"Number of Vascular access complications defined as the composite of arteriovenous fistula, arterial pseudoaneurysm, or arterial occlusion requiring intervention;",{"measure":53,"timeFrame":46},"Number of participants with Radial artery occlusion",{"measure":55,"description":56,"timeFrame":57},"Number of participants with Access site crossover","The inability to complete the procedure from the assigned arterial access site, requiring conversion from radial to femoral access or vice versa for procedure completion","Measured during procedure",{"measure":59,"timeFrame":46},"Number of other vascular access related complications",{"measure":61,"description":62,"timeFrame":57},"Total procedure time","The time from administration of local anesthesia to the time of removal of all interventional equipment",{"measure":64,"timeFrame":65},"Time to ambulation","Measured up to 24 hours after procedure completion",{"measure":67,"timeFrame":46},"Number of all cause death and cardiac death",{"measure":69,"description":70,"timeFrame":46},"Number of participants with Myocardial Infarction","The 4th Universal Definition of myocardial infarction",{"measure":72,"timeFrame":46},"Number of participants with Stroke",{"measure":74,"timeFrame":46},"Number of participants with unplanned coronary revascularization",{"measure":76,"description":77,"timeFrame":57},"Measure of Radiation Dose","Both air kerma and dose air product",{"measure":79,"timeFrame":57},"Fluoroscopy Time",{"measure":81,"timeFrame":57},"Contrast volume",{"measure":83,"description":84,"timeFrame":46},"Number of participants with Procedural Success","Using the National Cardiovascular Disease Registry (NCDR) definition",{"measure":86,"timeFrame":46},"Duration of hospital stay and frequency of same day discharge",{"measure":88,"description":89,"timeFrame":46},"Patient Preference Survey: Radial Vs Femoral Access","Participants will be asked which access site they would have preferred to have their procedure","ALL","18 Years",false,{"inclusion":94,"exclusion":99,"raw_text":112},[95,96,97,98],"Age 18 years and older","Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI","Has provided informed consent and agrees to participate","Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access",[100,101,102,103,104,105,106,107,108,109,110,111],"Primary PCI for STEMI","Planned right heart catheterization","Valvular heart disease requiring valve surgery within 30 days after the index procedure","Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)","Peripheral arterial disease prohibiting vascular access","Presence of bilateral internal mammary artery coronary bypass grafts","International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure","Planned staged PCI within 30 days after index procedure.","Any planned surgeries within 30 days after index procedure","Planned dual arterial access (for example for chronic total occlusion PCI)","Coexisting conditions that limit life expectancy to less than 30 days","Positive pregnancy test","Inclusion Criteria:\n\n* Age 18 years and older\n* Undergoing diagnostic angiography for ischemic symptoms with possible PCI, or undergoing planned urgent or elective PCI\n* Has provided informed consent and agrees to participate\n* Patients must be equally eligible to undergo cardiac catheterization via radial or femoral access\n\nExclusion Criteria:\n\n* Primary PCI for STEMI\n* Planned right heart catheterization\n* Valvular heart disease requiring valve surgery within 30 days after the index procedure\n* Hemodialysis access (arteriovenous fistula or graft) in the arm to be used for PCI in case of assignment to radial approach (the opposite arm may be used for radial access if a dialysis graft is present in one)\n* Peripheral arterial disease prohibiting vascular access\n* Presence of bilateral internal mammary artery coronary bypass grafts\n* International normalized ratio ≥1.5 while treated with oral vitamin K antagonists (i.e. warfarin) Receipt of oral factor Xa or IIa inhibitors ≤24 h before procedure\n* Planned staged PCI within 30 days after index procedure.\n* Any planned surgeries within 30 days after index procedure\n* Planned dual arterial access (for example for chronic total occlusion PCI)\n* Coexisting conditions that limit life expectancy to less than 30 days\n* Positive pregnancy test",[114,115],"ADULT","OLDER_ADULT",[117,135,150,165,181,193],{"facility":118,"status":8,"city":119,"state":120,"zip":121,"country":122,"contacts":123,"geoPoint":132},"San Francisco VA Medical Center","San Francisco","California","94121","United States",[124,129],{"name":125,"role":126,"phone":127,"email":128},"Jeffrey Zimmet, MD, PhD","CONTACT","415-221-4810","jeffrey.zimmet@va.gov",{"name":130,"role":131},"Kendrick Shunk, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":133,"lon":134},37.77493,-122.41942,{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":122,"contacts":140,"geoPoint":147},"Mayo Clinic Florida","Jacksonville","Florida","32224",[141,145],{"name":142,"role":126,"phone":143,"email":144},"Federico Simon","904-953-4205","Simon.FedericoRey@mayo.edu",{"name":146,"role":131},"Abdallah El Sabbagh, MD",{"lat":148,"lon":149},30.33218,-81.65565,{"facility":151,"status":8,"city":152,"state":153,"zip":154,"country":122,"contacts":155,"geoPoint":162},"Joseph Maxwell Cleland Atlanta VA Medical Center","Decatur","Georgia","30033",[156,160],{"name":157,"role":126,"phone":158,"email":159},"Nikki Leslie, RN","404-321-6111","nikki.leslie@va.gov",{"name":161,"role":131},"Kreton Mavromatis, MD",{"lat":163,"lon":164},33.77483,-84.29631,{"facility":166,"status":167,"city":168,"state":169,"zip":170,"country":122,"contacts":171,"geoPoint":178},"Henry Ford Hospital","NOT_YET_RECRUITING","Detroit","Michigan","48202",[172,176],{"name":173,"role":126,"phone":174,"email":175},"Michelle Butcher, RN","313-916-7614","mbutche1@hfhs.org",{"name":177,"role":131},"Khaldoon Alaswad, MD",{"lat":179,"lon":180},42.33143,-83.04575,{"facility":13,"status":8,"city":182,"state":183,"zip":184,"country":122,"contacts":185,"geoPoint":190},"Minneapolis","Minnesota","55407",[186],{"name":187,"role":126,"phone":188,"email":189},"Bavana Rangan, BDS, MPH, CCRP","612-863-3852","bavana.rangan@allina.com",{"lat":191,"lon":192},44.97997,-93.26384,{"facility":194,"status":8,"city":195,"state":196,"zip":197,"country":122,"contacts":198,"geoPoint":205},"Oklahoma Heart Hospital","Oklahoma City","Oklahoma","73120",[199,203],{"name":200,"role":126,"phone":201,"email":202},"Rebecca Straily, RN","405-608-1287","rstraily@okheart.com",{"name":204,"role":131},"Mazen Abu-Fadel, MD",{"lat":206,"lon":207},35.46756,-97.51643,[209,210],{"name":187,"role":126,"phone":188,"email":189},{"name":211,"role":126,"email":212},"Olga Mastrodemos","olga.mastrodemos@allina.com",[214],{"name":215,"affiliation":13,"role":131},"Emmanouil Brilakis, MD, PhD",[217],{"pmid":218,"type":219,"citation":220},"34637140","DERIVED","Flumignan RL, Trevisani VF, Lopes RD, Baptista-Silva JC, Flumignan CD, Nakano LC. Ultrasound guidance for arterial (other than femoral) catheterisation in adults. Cochrane Database Syst Rev. 2021 Oct 12;10(10):CD013585. doi: 10.1002\u002F14651858.CD013585.pub2.",[],{"nct_id":4,"conditions":223,"biomarkers":225},[224],"Ischemic Heart Disease",[],{"nct_id":4,"found":15,"summary":227,"prompt_version":237},{"design":228,"status":229,"heading":230,"summary":231,"follow_up":232,"word_count":233,"commitments":234,"compensation":235,"drugs_mentioned":236},"This is a Phase 4, open-label, randomized study involving about 3266 participants. You would be randomly assigned to either radial access or state-of-the-art femoral access; those in the femoral access group would then be randomly assigned to use either an 18-gauge or 21-gauge needle.","completed","REBIRTH Study: Comparing Access Methods for Cardiac Catheterization","This study, called REBIRTH, is looking at the best way to access your heart during a cardiac catheterization procedure. It compares two methods: Radial Access (through your wrist) and State-of-the-art femoral access (through your groin). The goal is to see which method leads to fewer bleeding issues and complications at the access site. You might be able to join if you are 18 or older, need a diagnostic angiography or planned PCI (percutaneous coronary intervention, a procedure to open blocked arteries), and can have either access method. Success in this study means a lower rate of bleeding and access site complications within 30 days. The study is currently recruiting a large number of participants.","Your progress will be evaluated for up to 30 days after the procedure.",114,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]