[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592252":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":31,"collaborators":33,"id":37,"slug":38,"hasResults":39,"nctId":40,"briefTitle":41,"officialTitle":42,"acronym":20,"eligibilityCriteria":43,"healthyVolunteers":39,"sex":44,"minAge":45,"maxAge":20,"enrollmentInfo":46,"targetDuration":20,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":60,"whyStopped":20,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":20},{"fullName":5,"class":6},"Transradial Technologies, LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"SAPH Device","EXPERIMENTAL","All patients who have the SAPH device used to achieve hemostasis",[13],"Device: Suction-Activated Patent Hemostasis (SAPH) Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Suction-Activated Patent Hemostasis (SAPH) Device","A compression device intended to achieve patient hemostasis of the radial artery",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Regulatory and Clinical Lead, PhD","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Regulatory and Clinical Lead","CONTACT","908-420-2707","jvargo1@outlook.com",{"type":32,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[34],{"name":35,"class":36},"RARAS CRO","UNKNOWN","100592252","clinical-use-study-of-saph-device-for-patent-hemostasis-after-a-transradial-procedure-100592252",false,"NCT06991010","Clinical Use Study of SAPH Device for Patent Hemostasis After a Transradial Procedure","One-arm, Prospective, Clinical Use Study of the Suction-Activated Patent Hemostasis (SAPH) Device After a Transradial Procedure","Inclusion Criteria:\n\n1. Patient is 21 years or older.\n2. Patient is scheduled to undergo a coronary or peripheral catheterization procedure requiring 5 or 6 Fr transradial sheath access (TRA) with planned same-day discharge\n3. Patient has a Reverse Barbeau test result of Type A, B or C (patent radial artery)\n4. Patient is able to understand informed consent language\n5. Patient is willing and able to sign informed consent and adhere to the protocol requirements\n\nExclusion Criteria:\n\n1. Patient had a prior ipsilateral TRA procedure\n2. Patient has scleroderma, vasculitis, or Raynaud's syndrome (primary or secondary)\n3. Patient has cellulitis overlying radial artery\n4. Patient requires uninterrupted oral systemic anticoagulation\n5. Patient has intolerance to standard anticoagulants used in TRA procedures\n6. Patient has non-palpable radial pulse or Reverse Barbeau test Type D response\n7. Patient is participating in another investigational study\n8. Patient is a prisoner\n9. Patient, in the principal investigator's opinion, would not be able to comply with protocol requirements including self-report of comfort and 30-day follow up\n10. Patient is receiving glycoprotein IIb\u002FIIIa inhibitors\n11. Patients with allergy to medical adhesives","ALL","21 Years",{"count":47,"type":48},50,"ESTIMATED","INTERVENTIONAL",[51],"NA","This is a prospective, multicenter study intended to provide supportive clinical information on the use of the SAPH device to achieve radial artery patent hemostasis after a transradial procedure.",[54],"Hemostasis of Arterial Punctures",[56,57,58,59],"Artery clamp","Transradial access","Radial artery patency","Radial artery hemostasis","NOT_YET_RECRUITING","2025-07-10",{"date":63,"type":64},"2025-07-15","ACTUAL",{"date":66,"type":48},"2025-08-01",{"date":68,"type":48},"2025-11-28",{"name":5,"class":6}]