Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-05 @ 5:24 PM
Study NCT ID:
NCT03265769
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2017-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Femoral or Radial Approach in Coronary Chronic Total Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 610}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2017-08-27', 'studyFirstSubmitQcDate': '2017-08-27', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Procedural success', 'timeFrame': '24 hours', 'description': 'Technical success without any in-hospital event'}], 'secondaryOutcomes': [{'measure': 'Major access site complications', 'timeFrame': '24 hours', 'description': 'Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Femoral approach', 'Radial approach', 'Chronic total occlusion'], 'conditions': ['Chronic Coronary Occlusion']}, 'referencesModule': {'references': [{'pmid': '35450683', 'type': 'DERIVED', 'citation': 'Gorgulu S, Kalay N, Norgaz T, Kocas C, Goktekin O, Brilakis ES. Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial. JACC Cardiovasc Interv. 2022 Apr 25;15(8):823-830. doi: 10.1016/j.jcin.2022.02.012.'}]}, 'descriptionModule': {'briefSummary': 'Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly performed using bilateral transfemoral access and 8 French guiding catheters. However, transfemoral approach (TFA) is associated with higher risk of vascular access complications.5 It has been reported that using transradial approach (TRA) reduces vascular complications and may be associated with a better clinical outcome. Transradial access is also used in complex PCI interventions.There is a growing body of evidence regarding the use of this approach also in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO consisted of single center and single operator experience. Besides, none of them is randomized. To fill in the gap, we sought to examine the technique and outcomes of transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.', 'detailedDescription': 'All consecutive patients referred for CTO PCI between August 2017 and July 2021 at Acibadem University Kocaeli Acibadem Hospital, Kocaeli; Erciyes University Medical Faculty, Kayseri; Istanbul University Cerrahpasa Medical Faculty, Haseki Cardiology Institute; Istanbul; Memorial Bahcelievler Hospital, Istanbul were screened for enrollment in the study. The exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe heart failure issues; (c)severe renal failure (d) failure to provide written informed consent.The radial access group consisted of patients with single or bi-radial approach. Any femoral artery puncture was considered a femoral case. For example, a crossover from any radial to femoral access was considered a femoral case. Procedures were performed by 4 interventional cardiologists, who are dedicated radial operators, at 4 different centers. The protocol was approved by the institutional review board and all patients provided written informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient with coronary total occlusion \\>3 months and indication for intervention\n\nExclusion Criteria:\n\n* Acute coronary syndrome within 3 months'}, 'identificationModule': {'nctId': 'NCT03265769', 'briefTitle': 'Femoral or Radial Approach in Coronary Chronic Total Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Acibadem University'}, 'officialTitle': 'Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial (FORT CTO TRIAL)', 'orgStudyIdInfo': {'id': 'Atadek2017/13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transradial approach', 'description': 'target vessel revascularization via radial access site is labeled as transradial approach', 'interventionNames': ['Other: radial access site']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transfemoral approach', 'description': 'target vessel revascularization via femoral access site is labeled as transfemoral approach', 'interventionNames': ['Other: femoral access site']}], 'interventions': [{'name': 'radial access site', 'type': 'OTHER', 'description': 'radial route', 'armGroupLabels': ['Transradial approach']}, {'name': 'femoral access site', 'type': 'OTHER', 'description': 'femoral route', 'armGroupLabels': ['Transfemoral approach']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Acibadem University', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Haseki Cradiology Institute', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Memorial Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}, {'city': 'Kayseri', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Sevket Gorgulu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Acibadem University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Acibadem University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}