[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659703":3},{"organization":4,"outcomesModule":7,"designInfo":64,"detailedDescription":11,"studyPopulation":11,"armGroups":74,"interventions":85,"overallOfficials":95,"centralContacts":100,"locations":108,"responsibleParty":128,"collaborators":11,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":11,"enrollmentInfo":141,"targetDuration":11,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":151,"overallStatus":154,"whyStopped":11,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"1-Year Composite event rate of all-cause death, myocardial Infarction, RA graft related revascularization, or RA graft failure",null,"At 1 year post-surgery",[14,18,22,24,28,31,34,36,38,41,44],{"measure":15,"description":16,"timeFrame":17},"1-year incidence of 4 point Major Adverse Cardiovascular Events (4P-MACE)","4P-MACE was defined as a composite of all-cause death, myocardial infarction (MI), stroke, or any repeat revascularization (PCI or CABG).","1 year post-surgery",{"measure":19,"description":20,"timeFrame":21},"1-year incidence of 3 point-MACE","3P-MACE was defined as a composite of cardiovascular death, myocardial infarction, or stroke","1 year post-CABG",{"measure":23,"description":11,"timeFrame":21},"1-year incidence of all-cause death",{"measure":25,"description":26,"timeFrame":27},"1-year incidence of cardiovascular death","Cardiovascular death includes death due to acute myocardial infarction, sudden cardiac death, heart failure, stroke, cardiovascular procedure, cardiovascular hemorrhage, or other cardiovascular causes, as adjudicated per ARC-2 definitions.","1-year post-CABG",{"measure":29,"description":30,"timeFrame":27},"1-year incidence of myocardial infarction","Myocardial infarction was defined using the Fifth Universal Definition of Myocardial Infarction, including .....",{"measure":32,"description":33,"timeFrame":27},"1-year incidence of RA graft-related myocardial infarction","RA graft-related myocardial infarction is defined as myocardial infarction occurring after CABG during follow-up, characterized by new or presumed new regional wall motion abnormality or loss of viable myocardium in the myocardial territory subtended by the RA graft, after exclusion of other graft-related or non-graft causes. Angiographic or CCTA evidence of new RA graft failure is supportive but not required.",{"measure":35,"description":11,"timeFrame":27},"1-year incidence of stroke",{"measure":37,"description":11,"timeFrame":21},"1-year incidence of any revascularization",{"measure":39,"description":40,"timeFrame":21},"1-year incidence of RA graft-related revascularization","RA graft-related revascularization is defined as any PCI or CABG involving the RA graft or its target vessel.",{"measure":42,"description":43,"timeFrame":21},"1-year incidence of patient-level RA graft failure (and its components)","RA graft failure is defined as modified FitzGibbon grade B, S, or O on CCTA, assessed by the independent Imaging Core Laboratory.\n\nComponents include:\n\nGrade B: maximum diameter stenosis \\>50% but not occluded; Grade S: \"string sign\" (patent but diffusely narrowed, visual diameter \\\u003C1 mm); Grade O: occlusion. A patient is considered to have a patient-level event if any RA graft is graded B, S, or O.",{"measure":45,"description":46,"timeFrame":21},"1-year Median RA graft Diameter","Diameter of the RA graft is measured on postoperative CCTA. The minimum diameter along the RA graft is used; grade S grafts are assigned a diameter of 1 mm, and grade O grafts are assigned a diameter of 0 mm.",[48,52,55,58,61],{"measure":49,"description":50,"timeFrame":51},"Median intraoperative RA graft blood flow","RA graft flow will be measured by transit-time flow measurement (TTFM) after completion of the RA graft anastomosis, reported in mL\u002Fmin.","Intraoperative",{"measure":53,"description":54,"timeFrame":51},"Median intraoperative RA graft pulsatility index","Pulsatility index (PI) of the RA graft measured by TTFM after completion of the RA graft anastomosis.",{"measure":56,"description":57,"timeFrame":51},"Incidence of intraoperative RA graft reverse flow","Proportion of participants with any reverse flow in the RA graft detected by TTFM after completion of the RA graft anastomosis.",{"measure":59,"description":43,"timeFrame":60},"7-day incidence of patient-level RA graft failure (and its components)","7 days post-CABG",{"measure":62,"description":46,"timeFrame":63},"7-day Median RA graft diameter","7 day post-CABG",{"allocation":65,"interventionModel":66,"interventionModelDescription":11,"primaryPurpose":67,"observationalModel":11,"timePerspective":11,"maskingInfo":68},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":69,"maskingDescription":70,"whoMasked":71},"DOUBLE","In addition to participants and outcomes assessors, the following parties are masked to treatment allocation: CCTA image readers at the independent imaging core laboratory, members of the independent endpoint adjudication committee, and statisticians performing analyses before unblinding. The operating surgeon and site staff involved in the surgical procedure are not masked because of the nature of the intervention.",[72,73],"PARTICIPANT","OUTCOMES_ASSESSOR",[75,80],{"label":76,"type":77,"description":11,"interventionNames":78},"Fasciotomy and Predilation Arm","EXPERIMENTAL",[79],"Procedure: Radial Artery Harvesting With Fasciotomy and Predilation",{"label":81,"type":82,"description":11,"interventionNames":83},"No Fasciotomy or Predilation Arm","ACTIVE_COMPARATOR",[84],"Procedure: Radial Artery Harvesting Without Fasciotomy or Predilation",[86,91],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":11},"PROCEDURE","Radial Artery Harvesting With Fasciotomy and Predilation","After pedicled radial artery (RA) harvesting, a single-aspect fasciotomy of the graft pedicle is performed to release the fascial sheath along the harvested RA graft, with care taken to avoid injury to the RA and surrounding structures. The harvested RA graft is then predilated with a verapamil plus nitroglycerin (VG) solution (verapamil 5 mg, nitroglycerin 2.5 mg, heparin 500 U, 8.4% NaHCO₃ 0.2 mL, and Ringer's lactate solution 300 mL) to relieve vasospasm, restore luminal caliber, and assess graft integrity and the adequacy of branch ligation. The procedure is performed in accordance with a standardized surgical protocol. Any deviations deemed clinically necessary are documented.",[76],{"type":87,"name":92,"description":93,"armGroupLabels":94,"otherNames":11},"Radial Artery Harvesting Without Fasciotomy or Predilation","Pedicled radial artery (RA) harvesting is performed through a forearm incision along the RA course, preserving the surrounding fascia and adipose tissue. The RA is dissected bluntly under direct visualization or with permitted assistance, avoiding direct clamping of the vessel. Following harvesting, the RA graft is prepared without fasciotomy or VG solution predilation.",[81],[96],{"name":97,"affiliation":98,"role":99},"Yunpeng Zhu","Ruijin Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China","PRINCIPAL_INVESTIGATOR",[101,105],{"name":97,"role":102,"phone":103,"phoneExt":11,"email":104},"CONTACT","+86 02164370045","zyp12220@rjh.com.cn",{"name":106,"role":102,"phone":11,"phoneExt":11,"email":107},"Haonan Huang","hhn3141547334@sjtu.edu.cn",[109],{"facility":110,"status":11,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"Ruijin Hospital, Shanghai Jiao Tong University School of Medicine","Shanghai","Shanghai Municipality","200025","China","CN",{"type":117,"coordinates":118},"Point",[119,120],121.45806,31.22222,{"lat":120,"lon":119},[123,124,126],{"name":97,"role":102,"phone":103,"phoneExt":11,"email":104},{"name":125,"role":99,"phone":11,"phoneExt":11,"email":11},"Yunepng Zhu",{"name":106,"role":127,"phone":11,"phoneExt":11,"email":11},"SUB_INVESTIGATOR",{"type":99,"investigatorFullName":129,"investigatorTitle":130,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Zhu yunpeng","Director of clinical research, Department of Cardiovascular Surgery","100659703","fasciotomy-and-predilation-for-radial-artery-grafts-in-cabg-100659703",false,"NCT07868692","Fasciotomy and Predilation for Radial Artery Grafts in CABG","Effect of Pedicled Harvesting With FascIotomy and PreDilation on Radial Artery Graft Outcomes After Coronary Artery Bypass Grafting: A Multicenter, Randomized, Participant and Assessor Blinded, Parallel- Controlled, Superiority Trial","RAPID-CABG","Inclusion Criteria:\n\n* Scheduled for coronary artery bypass grafting (CABG) and planned use of radial artery (RA) grafts\n\nExclusion Criteria:\n\n* Emergency CABG or redo CABG\n* Planned concomitant cardiac or non-cardiac surgery\n* Contraindications to coronary computed tomography angiography (CCTA), including pregnancy, uncontrolled severe iodine contrast allergy, or severe renal insufficiency (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²)\n* Any condition that, in the investigator's judgment, would preclude safe participation, completion of informed consent, or follow-up\n* Inability to provide written informed consent","ALL","18 Years",{"count":142,"type":143},314,"ESTIMATED","INTERVENTIONAL",[146],"NA","The goal of this clinical trial is to learn if a new way to prepare a radial artery graft during coronary artery bypass grafting (CABG) can improve outcomes for adults having this surgery. CABG is a heart surgery that uses a blood vessel to bypass blocked arteries in the heart. The radial artery is a blood vessel taken from the arm and used as a graft.\n\nThe new way combines two steps:\n\nFasciotomy: a small cut in the tissue around the graft to release pressure.\n\nPredilation: gently filling the graft with a medicine solution to widen it and check for damage.\n\nResearchers will compare this new way with the standard way of harvesting the radial artery.\n\nThe main questions it aims to answer are:\n\nDoes the new way lower the chance of death, heart attack, another procedure to restore blood flow through the graft, or graft failure within 1 year after surgery?\n\nDoes it improve blood flow and keep the radial artery graft open?\n\nIs it safe?\n\nParticipants will:\n\nBe adults scheduled to have CABG using a radial artery graft.\n\nBe assigned by chance to one of two groups: the new way or the standard way.\n\nHave CABG surgery.\n\nVisit the clinic at 7 days, 30 days, 6 months, and 12 months after surgery.\n\nHave a special heart scan (coronary computed tomography angiography, CCTA) at 7 days and 12 months to check the graft.\n\nAllow researchers to collect medical information and record any health problems.\n\nResearchers will compare the two groups to see if the new way works better than the standard way.",[149,150],"Coronary Artery Bypass","Radial Artery Grafts",[152,153],"CABG","Radial artery grafts","NOT_YET_RECRUITING","2026-10-04",{"date":157,"type":158},"2026-10-09","ACTUAL",{"date":160,"type":143},"2026-10",{"date":162,"type":143},"2029-06",{"name":5,"class":6},1]