Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2026-03-01 @ 2:46 AM
Study NCT ID:
NCT03273218
Status:
COMPLETED
Last Update Posted:
2019-03-06
First Post:
2017-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared to JudKins cathETers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-20', 'size': 421878, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2017-09-05T09:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2016-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-05', 'studyFirstSubmitDate': '2017-08-19', 'studyFirstSubmitQcDate': '2017-09-05', 'lastUpdatePostDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Produce time for the coronary angiography', 'timeFrame': 'Day 0 (corresponding to time point of produce) assessed by intention - to - tresat analysis (IIT)', 'description': 'Produce time (min) was defined as the time from the insertion of the first diagnostic coronary catheter in the sheath to the exist of the las diagnostic catheter the sheath.'}], 'secondaryOutcomes': [{'measure': 'Fluoroscopy time', 'timeFrame': 'Day 0 (corresponding to time point of produce)', 'description': 'Fluoroscopy time (min)was defined as fluoroscopy time during the procedure (between groups)'}, {'measure': 'Contrast Volume used', 'timeFrame': 'Day 0 (corresponding to time point of produce)', 'description': 'contrast volume used (ml) was defined as the contrast volume between groups used for completion of coronary angiogram'}, {'measure': 'Radial artery Spasm', 'timeFrame': 'Day 0 (corresponding to time point of produce). The radial artery spasm was recorded like YES or NOT.(registry did by nurse from beginning to end of coronary angiography)', 'description': 'Radial artery Spasm was defined as the discomfort or pain in the arm, between groups'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['coronary angiography', 'diagnosctic transradial catheter', 'transradial catheter'], 'conditions': ['Acute Coronary Syndrome']}, 'descriptionModule': {'briefSummary': 'The aim of this study was to assess effectiveness and safety of Tiger (5Fr) vs Judkins (5Fr) catheters, in coronariography via the right transradial approach.\n\nThis was a prospective, randomized, study of paralled design. Consecutive patients with acute coronary syndrome (ACS), eligible for coronary angiography, was randomized after successuful cannulation of right artery and informed consent to either Tiger or Judkins catheters.', 'detailedDescription': 'analyzed a total of 120 consective diagnostic coronary angioggraphy cases from the right radial approach. Of these 60 cases were performed with single catheter (Tiger) and 60 cases were performed with conventional catheters (Judkins). The patients of both group were overall well balanced for gender, age, risk factors, height, weight and body surface area. Diagnostic angiograms were successfully achieved in all cases via the radial approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* indication for coronary angiography\n\nExclusion Criteria:\n\n* negative Allen´s test\n* Chronic renal failure (to preserve the right radial artery for potencial arteriovenous shunting)\n* Hemodynamic instability\n* coronary artery bypass grafting'}, 'identificationModule': {'nctId': 'NCT03273218', 'acronym': 'TICKET', 'briefTitle': 'Effectiveness of the Tiger Catheter on Transradial Coronariography: Randomized Compared to JudKins cathETers', 'organization': {'class': 'OTHER', 'fullName': 'Hospital San Roque'}, 'officialTitle': 'Effectiveness of the Tiger Catheter as a Simple Multipurpuse Catheter in Transradial Coronariography: Randomized Comparerd to Judkins Catheters', 'orgStudyIdInfo': {'id': 'HospitalSR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tiger catheter', 'description': 'Tiger simple multipurpose catheter compared to Judkins catheters', 'interventionNames': ['Device: Tiger catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Judkins catheter', 'description': 'Judkins right and judkins left catheter', 'interventionNames': ['Device: Judkins catheter']}], 'interventions': [{'name': 'Tiger catheter', 'type': 'DEVICE', 'otherNames': ['Tiger'], 'armGroupLabels': ['Tiger catheter']}, {'name': 'Judkins catheter', 'type': 'DEVICE', 'otherNames': ['judkins right', 'judkins left'], 'armGroupLabels': ['Judkins catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Córdoba', 'country': 'Argentina', 'facility': 'Hospital San Roque', 'geoPoint': {'lat': -31.40648, 'lon': -64.18853}}], 'overallOfficials': [{'name': 'Marcelo OLIVA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital San Roque'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The aim of this study was to assess effectiveness and safety of Tiger vs Judkins catheters, in coronary angiography.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Marcelo Alberto OLIVA', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'interventional cardiologist', 'investigatorFullName': 'Marcelo Alberto OLIVA', 'investigatorAffiliation': 'Hospital San Roque'}}}}