Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT07060820
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2025-07-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association Between Radial Artery Access Point and Radial Artery Spasm During Transradial Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-01', 'studyFirstSubmitDate': '2025-07-02', 'studyFirstSubmitQcDate': '2025-07-02', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Radial Artery Spasm during Transradial Coronary Angiography', 'timeFrame': 'During the procedure'}, {'measure': 'Incidence of Radial Artery Spasm (RAS) during transradial coronary angiography', 'timeFrame': 'During the procedure', 'description': 'Radial artery spasm will be defined by the presence of at least two of the following: persistent forearm pain, pain during catheter manipulation, difficult catheter manipulation due to arterial spasm, pain during sheath removal, and significant resistance during sheath removal.'}], 'secondaryOutcomes': [{'measure': 'Incidence of access site complications', 'timeFrame': 'Within 5 days post-procedure', 'description': 'Number of patients experiencing access site complications including hematoma, bleeding, or occlusion within 5 days after the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transradial Access', 'Radial Artery Spasm', 'Coronary Angiography'], 'conditions': ['Coronary Artery Disease', 'Radial Artery Spasm']}, 'descriptionModule': {'briefSummary': 'This prospective clinical study aims to investigate whether the puncture site distance from the radial styloid process affects the incidence of radial artery spasm (RAS) during coronary angiography. Patients undergoing coronary angiography via radial access will be randomized into two groups based on the puncture site distance: 0-20 mm and \\>21 mm from the styloid process. The procedure will be performed by experienced interventional cardiologists using standard techniques and medications. The primary goal is to determine if a specific puncture site reduces the incidence of RAS, which is a common complication during transradial procedures. The study will also record procedural details and monitor for other complications to identify the optimal puncture site for reducing RAS and improving patient comfort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdults aged 18 years and older. Patients scheduled for coronary angiography via transradial access. Patients with a palpable radial artery pulse. Patients with a normal Allen test.\n\nExclusion Criteria:\n\nAbnormal Allen test results. Absence of palpable radial artery pulse. History of prior transradial coronary angiography with hemodynamic instability. Patients with severe comorbid conditions precluding safe participation in the study.'}, 'identificationModule': {'nctId': 'NCT07060820', 'briefTitle': 'Association Between Radial Artery Access Point and Radial Artery Spasm During Transradial Procedures', 'organization': {'class': 'OTHER', 'fullName': 'Mersin Medicalpark Hastanesi'}, 'officialTitle': 'Association Between Radial Artery Access Point and Radial Artery Spasm During Transradial Procedures', 'orgStudyIdInfo': {'id': 'MMP-KAR-VA-01'}, 'secondaryIdInfos': [{'id': 'ETTICS', 'type': 'OTHER', 'domain': 'EC-2022/03'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0-20 mm Puncture Distance Group', 'interventionNames': ['Procedure: Radial Artery Puncture at 0-20 mm']}, {'type': 'EXPERIMENTAL', 'label': '21 mm Puncture Distance Group', 'interventionNames': ['Procedure: Radial Artery Puncture at >21 mm']}], 'interventions': [{'name': 'Radial Artery Puncture at 0-20 mm', 'type': 'PROCEDURE', 'description': 'Radial artery puncture performed 0-20 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its impact on the incidence of radial artery spasm (RAS).', 'armGroupLabels': ['0-20 mm Puncture Distance Group']}, {'name': 'Radial Artery Puncture at >21 mm', 'type': 'PROCEDURE', 'description': 'Radial artery puncture performed at a distance greater than 21 mm proximal to the radial styloid process during transradial coronary angiography to evaluate its impact on the incidence of radial artery spasm (RAS).', 'armGroupLabels': ['21 mm Puncture Distance Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33200', 'city': 'Mersin', 'state': 'Mezitli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Vedat Aslan, MD', 'role': 'CONTACT', 'email': 'dr.vedataslan@gmail.com', 'phone': '0905054418064'}], 'facility': 'VM Medicalpark Mersin Hospital', 'geoPoint': {'lat': 36.81196, 'lon': 34.63886}}], 'centralContacts': [{'name': 'Vedat Aslan', 'role': 'CONTACT', 'email': 'dr.vedataslan@gmail.com', 'phone': '0905054418064'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data (IPD) will not be shared because the study is a single-center observational procedural study with limited resources for external data sharing and monitoring. Data can be shared upon reasonable request to the principal investigator in compliance with local regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mersin Medicalpark Hastanesi', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}