Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2025-12-25 @ 5:04 PM
Study NCT ID:
NCT05790603
Status:
RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'One of the primary outcome of radial artery occlusion will be assessed by masking the assessor. The data analyzers will also be blinded.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2024-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence early radial artery occlusion', 'timeFrame': 'Within 24 hours after CAG/PCI', 'description': 'RAO occurs within 24 hours after CAG/PCI'}], 'secondaryOutcomes': [{'measure': 'Compression time', 'timeFrame': 'through hemostasis completion，estimated to be an average of 3~6hours', 'description': 'The interval from the time of sheath removal to the time of hemostasis removal'}, {'measure': 'Incidence of access site bleeding', 'timeFrame': 'Within 24 hours after CAG/PCI', 'description': 'Access site bleeding within 24 hours after CAG/PCI'}, {'measure': 'Incidence of hematoma', 'timeFrame': 'through hemostasis completion，estimated to be an average of 4~6hours', 'description': 'The incidence of subcutaneous hematoma in the distal skin of the compression site 24 h after the removal of the compression device'}, {'measure': 'Incidence of 30d radial artery occlusion', 'timeFrame': 'Within 30 days after CAG/PCI', 'description': 'RAO occurs within 30 days after CAG/PCI'}, {'measure': 'The degree of pain', 'timeFrame': 'baseline; 24 hours after PCI', 'description': 'Pain level is classified as painless: 0; mild pain: 1\\~3; moderate pain: 4\\~6; severe pain: 7\\~10.'}, {'measure': 'numbness', 'timeFrame': 'baseline; 24 hours after PCI', 'description': 'Numbness level is classified as no numbness with 0, mild numbness: 1\\~2; moderate numbness: 3; severe numbness:4\\~5'}, {'measure': 'Hand swelling', 'timeFrame': 'baseline; 24 hours after PCI', 'description': 'The circumference diameter of both hands was measured using a tape gauge contrast.'}, {'measure': 'pseudoaneurysm', 'timeFrame': 'Within 24 hours after PCI', 'description': 'It refers to the lumen of the same as the artery formed by the blood through the perivascular tissue after arterial puncture.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention', 'Radial artery hemostasis', 'Quantitative pressure', 'Randomized controlled trial'], 'conditions': ['Percutaneous Coronary Intervention', 'Hemostasis']}, 'referencesModule': {'references': [{'pmid': '29880098', 'type': 'BACKGROUND', 'citation': 'Petroglou D, Didagelos M, Chalikias G, Tziakas D, Tsigkas G, Hahalis G, Koutouzis M, Ntatsios A, Tsiafoutis I, Hamilos M, Kouparanis A, Konstantinidis N, Sofidis G, Pancholy SB, Karvounis H, Bertrand OF, Ziakas A. Manual Versus Mechanical Compression of the Radial Artery After Transradial Coronary Angiography: The MEMORY Multicenter Randomized Trial. JACC Cardiovasc Interv. 2018 Jun 11;11(11):1050-1058. doi: 10.1016/j.jcin.2018.03.042.'}, {'pmid': '3233513', 'type': 'BACKGROUND', 'citation': 'Deitrich-MacLean G, Walden T. Distinguishing teaching interactions of physically abusive from nonabusive parent-child dyads. Child Abuse Negl. 1988;12(4):469-79. doi: 10.1016/0145-2134(88)90064-6.'}, {'pmid': '35694680', 'type': 'BACKGROUND', 'citation': 'Kulyassa P, Nemeth BT, Ehrenberger R, Ruzsa Z, Szuk T, Fehervari P, Engh MA, Becker D, Merkely B, Edes IF. The Design and Feasibility of the: Radial Artery Puncture Hemostasis Evaluation - RAPHE Study, a Prospective, Randomized, Multicenter Clinical Trial. Front Cardiovasc Med. 2022 May 27;9:881266. doi: 10.3389/fcvm.2022.881266. eCollection 2022.'}, {'pmid': '35589232', 'type': 'RESULT', 'citation': 'Eid-Lidt G, Reyes-Carrera J, Farjat-Pasos JI, Saenz AL, Bravo CA, Rangel SN, Salido DZ, Vega Servin NS, Soto-Lopez ME, Gaspar J. Prevention of Radial Artery Occlusion of 3 Hemostatic Methods in Transradial Intervention for Coronary Angiography. JACC Cardiovasc Interv. 2022 May 23;15(10):1022-1029. doi: 10.1016/j.jcin.2022.03.011.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this clinical trial is to compare the hemostatic effect of 2 hemostatic devices with or without quantitative pressure on radial arteries after coronary angiography (CAG) or percutaneous coronary intervention (PCI). The main questions aims to answer:\n\n* What is the hemostatic effect of the patent hemostatic device with quantitative pressure after percutaneous coronary intervention?\n* What are the precise hemostatic pressure and hemostatic time of the radial artery after CAG/PCI? Participants will be randomly assigned to the intervention group (IG) and control group (CG). The IG will use patent hemostatic device with quantitative pressure (PHDQP-Band, China) while the CG will use the conventional radial artery hemostatic device (TR-Band, Japan) without pressure monitoring.\n\nThe primary outcomes is incidence of 24h radial artery occlusion (24h RAO). Secondary outcomes include time to hemostasis, bleeding, hematoma, 30d radial artery occlusion (30d RAO), pain, hand swelling, numberness, pseudoaneurysm, and radial artery stenosis.', 'detailedDescription': "The objective of this clinical trial is to compare the hemostatic effect of 2 hemostatic devices with or without quantitative pressure on radial arteries after percutaneous coronary intervention. The main questions aims to answer:\n\n* What is the hemostatic effect of the patent hemostatic device after percutaneous coronary intervention?\n* What are the precise hemostasis pressure and hemostasis time of the radial artery after percutaneous coronary intervention?\n\nParticipants will be randomly assigned to the intervention group (IG) and control group (CG).\n\nFor the participants assigned to the IG, the radial systolic pressure will be measured after TRA procedure. The PHD-Band with quantitative pressure ( WEGO Medical Products Group CO. LTD, China) will be placed at the entry site of the sheath. Connecting the hemostatic devices to the electric pneumatic machine with a connecting cable. After removing the radial sheath, the puncture site will be compressed by operator's hand. The PHD-Band with quantitative pressure will be inflated with specific pressure radial systolic pressure plus 10mmHg) and the hand will slowly release the pressure. If bleeding occurs, the PHD-Band will be deflated with 5-10mmHg automatically by parameter setting with the electric pneumatic machine until the bleeding stops. The PHD-Band will be deflated with20 mmHg, 40 mmHg of decreased pressure following 1h and 2h after the procedure. After 3 hours, the hemostatic pressure will be released to 45mmHg and the PHD-Band will be removed if no bleeding occurs. If rebleeding occurs, the band will be inflated according to the previous pressure for another an hour until bleeding stops.\n\nFor the participants assigned to the CG, the TR-Band (Terumo Medical Corporation, Japan) will be placed at the entry site of the sheath after TRA procedure and inflated with 10 mL of air and the radial sheath will be removed with hand compression. Another 5 mL of air will be inflated and the operator's hand will slowly release the pressure. The TR band will be inflated until bleeding stopped with the maximum air volume no more than 18ml. The band will be deflated with 1 mL of air hourly for the following 2 hours after the procedure. After 3 hours, the band will be deflated with 4 mL of air first and then all volume of the rest air if no bleeding occurs and then the band will be removed if no bleeding occurs. If rebleeding occurs, the band will be inflated with 1 mL of air until bleeding stops .\n\nFor all enrolled participants, the investigators will record the complications such as bleeding, subcutaneous hematoma, pain, hand swelling, numbness, pseudoaneurysm after the operation. Radial artery occlusion, subcutaneous hematoma, pseudoaneurysm, and radial artery stenosis were confirmed by arterial ultrasound within 24 hours and 30 days after surgery."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients undergoing coronary angiography or percutaneous coronary intervention via the radial artery; Positive Allen's test result; Willing to sign informed consent.\n\nExclusion Criteria:\n\nRadial artery malformation； Chronic kidney disease with eGFR\\<30ml/min.1.73m2; Cirrhosis of the liver; Coagulation disfunction; Patients treated with IIb / IIIa receptor antagonist."}, 'identificationModule': {'nctId': 'NCT05790603', 'acronym': 'PCI', 'briefTitle': 'Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Effect of Patent Hemostatic Device (PHD) With Quantitative Pressure on Radial Artery Hemostasis After CAG/PCI：a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2023SF05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'PHD-band Group', 'interventionNames': ['Device: Intervention group with PHD-Band']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'TR-band Group', 'interventionNames': ['Device: Control group with TR-Band']}], 'interventions': [{'name': 'Intervention group with PHD-Band', 'type': 'DEVICE', 'otherNames': ['Brand name: WEGO Medical Products Group CO. LTD, China'], 'description': 'The initial compression pressure was systolic blood pressure plus 10mmHg. Pressure will be released by 20mmHg and 40mmHg 1 hour and 2 hours respectively after the surgery and then the band will be removed after 3 hours if no bleeding occurs. The compression will continue if bleeding occurs.', 'armGroupLabels': ['Intervention group']}, {'name': 'Control group with TR-Band', 'type': 'DEVICE', 'otherNames': ['Brand name: Terumo Medical Corporation, Japan'], 'description': 'TR-Band will be inflated with 15 mL of air The band will be deflated with 1 mL of air hourly for the following 2 hours after the procedure. After 3 hours, the band will be removed if no bleeding occurs. If rebleeding occurs, the band will be inflated with appropriate volume of air until bleeding stops .', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100053', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenhui Tao, Master', 'role': 'CONTACT', 'email': 'terry1018china@163.com', 'phone': '+8613811839842'}], 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhenhui Tao', 'role': 'CONTACT', 'email': 'terry1018china@163.com', 'phone': '+8613811839842'}], 'overallOfficials': [{'name': 'Zhenhui Tao', 'role': 'STUDY_CHAIR', 'affiliation': 'Peking University First Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}