Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2025-12-31 @ 3:08 PM
Study NCT ID:
NCT03986151
Status:
COMPLETED
Last Update Posted:
2021-03-12
First Post:
2019-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anatomical sNuffbox for Coronary anGiography and IntervEntions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}], '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': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1042}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-09', 'studyFirstSubmitDate': '2019-06-11', 'studyFirstSubmitQcDate': '2019-06-13', 'lastUpdatePostDateStruct': {'date': '2021-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of right radial artery occlusion', 'timeFrame': '≥30 days after CAG or PCI'}], 'secondaryOutcomes': [{'measure': 'Rate of successful insertion of the sheath', 'timeFrame': 'Immediately post-procedurally'}, {'measure': 'Duration of sheath insertion procedure', 'timeFrame': 'Immediately post-procedurally'}, {'measure': 'Rate of successful completion of coronary angiography', 'timeFrame': 'Immediately post-procedurally'}, {'measure': 'Rate of successful completion of percutaneous coronary intervention', 'timeFrame': 'Immediately post-procedurally'}, {'measure': 'Total Contrast volume', 'timeFrame': 'Immediately post-procedurally'}, {'measure': 'Total Fluoroscopy time', 'timeFrame': 'Immediately post-procedurally'}, {'measure': 'Total Radiation Dose', 'timeFrame': 'Immediately post-procedurally'}, {'measure': 'Total Procedure Time', 'timeFrame': 'Immediately post-procedurally'}, {'measure': 'Time required for hemostasis', 'timeFrame': '1-6 hours'}, {'measure': 'Postprocedural Hematoma (modified EASY class)', 'timeFrame': '3 hours'}, {'measure': 'Rate of distal radial artery occlusion', 'timeFrame': '≥30 days after CAG or PCI'}, {'measure': 'Pain associated with the procedure: Pain scale 0-10', 'timeFrame': '1 hour', 'description': 'Pain scale 0-10. A visual anlog pain scale 0-10 will be shown to the patient post-precedurally. 0=no pain, 10=worst pain. Patient will be asked to report the severity of the pain associated with the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary angiography', 'radial access', 'distal radial access', 'anatomical snuffbox', 'radial artery occlusion'], 'conditions': ['Coronary Artery Disease', 'Vascular Access Complication']}, 'descriptionModule': {'briefSummary': 'This randomized, single-center, prospective study seeks to compare the conventional radial approach with the recently described distal radial approach (anatomical snuffbox) concerning the patency of the radial artery in patients subjected to coronary angiography or percutaneous coronary intervention.', 'detailedDescription': "Transradial approach has become the standard approach for coronary angiography (CAG) and percutaneous coronary intervention (PCI). The current ESC/EACTS guidelines of myocardial revascularization support using radial approach (RA) rather than femoral approach (FA) if the operators are experts for RA. Recently, an alternative transradial access has been suggested at the anatomical snuffbox, with potential additional benefits including a reduction in radial artery occlusion rate (which allows reintervention through the same access site and potential use as a graft), a decrease in other local vascular complications, shorter hemostasis duration, patients' intra and post procedural comfort and shorter recovery time. However, the feasibility of PCI via snuffbox approach is still concerned due to the lack of data. Therefore, the aim of the study is to compare the two approaches concerning the patency of the radial artery ≥30 days after the intervention with Doppler in a randomized way. Due to the anastomosis of the distal radial artery with the superficial palmar arch, even in case of total radial artery occlusion within the anatomical snuffbox, the antegrade blood flow may be preserved and, therefore, decreased incidents of radial artery occlusion are expected in the right distal radial artery approach group. The mean diameter of radial artery at the anatomical snuffbox is 2.4 mm, whereas the mean diameter of the radial artery at the forearm is 2.7 mm, and this could potentially contribute to shorter hemostasis duration."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for coronary angiography\n* Informed consent\n\nExclusion Criteria:\n\n* Non palpable right radial artery\n* Prior complicated right transradial intervention (radial artery dissection, perforation, occlusion)\n* Prior CABG\n* STEMI\n* Hemodynamic instability\n* Anatomical restrictions (fistula, etc)'}, 'identificationModule': {'nctId': 'NCT03986151', 'acronym': 'ANGIE', 'briefTitle': 'Anatomical sNuffbox for Coronary anGiography and IntervEntions', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Patras'}, 'officialTitle': 'Anatomical sNuffbox for Coronary anGiography and IntervEntions', 'orgStudyIdInfo': {'id': '11994/6-5-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional radial access', 'interventionNames': ['Procedure: Coronary angiography +/- percutaneous coronary intervention']}, {'type': 'EXPERIMENTAL', 'label': 'Distal radial access', 'interventionNames': ['Procedure: Coronary angiography +/- percutaneous coronary intervention']}], 'interventions': [{'name': 'Coronary angiography +/- percutaneous coronary intervention', 'type': 'PROCEDURE', 'description': 'Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)', 'armGroupLabels': ['Conventional radial access', 'Distal radial access']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26504', 'city': 'Pátrai', 'state': 'Achaia', 'country': 'Greece', 'facility': 'University Hospital of Patras', 'geoPoint': {'lat': 38.2462, 'lon': 21.73508}}], 'overallOfficials': [{'name': 'Grigorios Tsigkas, MD, Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Patras'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Patras', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiology consultant', 'investigatorFullName': 'Grigorios Tsigkas', 'investigatorAffiliation': 'University Hospital of Patras'}}}}