Ignite Creation Date:
2025-12-25 @ 1:02 AM
Ignite Modification Date:
2026-02-25 @ 2:07 AM
Study NCT ID:
NCT02625493
Status:
COMPLETED
Last Update Posted:
2017-02-03
First Post:
2015-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Preference for Radial Versus Femoral Vascular Access
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D057240', 'term': 'Patient Preference'}], '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'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-02', 'studyFirstSubmitDate': '2015-11-30', 'studyFirstSubmitQcDate': '2015-12-04', 'lastUpdatePostDateStruct': {'date': '2017-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of times that patients prefer transradial in future percutaneous coronary procedure, when given a discrete choice via a questionnaire.', 'timeFrame': '30 days', 'description': 'When given the discrete choice, which access site patients would prefer in future percutaneous coronary procedures.'}, {'measure': 'Percentage of patients that wants to be directly involved in the decision-making process when making the choice for access site in future coronary procedures, by use of a questionnaire.', 'timeFrame': '30 days', 'description': 'The valuation of participation in decision-making on the choice of vascular access together with the interventional cardiologist'}], 'primaryOutcomes': [{'measure': 'The best and worst treatment characteristics of transradial and transfemoral access, by using a software-generated Best-Worst Scaling Questionnaire - case 2', 'timeFrame': '30 days', 'description': 'Best-Worst Scaling Questionnaire will be used to assess which treatment characteristics patients find most and least desirable in percutaneous coronary procedures performed via transradial and transfemoral access.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Percutaneous coronary intervention', 'Patient Preference', 'Radial access', 'Femoral access', 'Coronary angiography', 'Shared decision making'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '28470994', 'type': 'DERIVED', 'citation': 'Kok MM, Weernink MGM, von Birgelen C, Fens A, van der Heijden LC, van Til JA. Patient preference for radial versus femoral vascular access for elective coronary procedures: The PREVAS study. Catheter Cardiovasc Interv. 2018 Jan 1;91(1):17-24. doi: 10.1002/ccd.27039. Epub 2017 May 4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the preference of patients regarding the vascular access site in future coronary procedures. We hypothesize that patients prefer the lesser invasive procedure via radial access.', 'detailedDescription': 'Rationale: To explore patient preference for vascular access site in percutaneous coronary procedures, by assessing the perceived importance of benefits and risks of both transradial access and transfemoral access. In addition, direct preference for vascular access and preference for shared decision-making were evaluated.\n\nObjective: To investigate the patient preference of vascular access -transradial versus transfemoral- in future percutaneous coronary procedures, by use of the Best-Worst Scaling.\n\nStudy design: Single-center, prospective, observational registry\n\nStudy population: A consecutive series of patients, who between June and August 2014, underwent elective coronary procedures at Thoraxcentrum Twente in Enschede.\n\nIntervention: All subjects will receive a questionnaire containing basic baseline questions and a best-worst scaling scenario in which they were asked to indicate the most and least desirable characteristics of the vascular access approach.\n\nFurthermore, their direct preference was asked and to which extent they preferred to participate in the decision-making process regarding the choice for vascular access route in future percutaneous coronary procedures.\n\nMain study endpoints:\n\n* The primary endpoint is the patient preference on specific treatment characteristics with regard to vascular access in coronary procedures.\n* Secondary endpoints include\n\n 1. direct patient preference for transradial access or transfemoral access\n 2. the valuation of participation in decision-making on the choice of vascular access together with the interventional cardiologist.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A consecutive series of patients, who between June and August 2014, underwent elective coronary procedures at Thoraxcentrum Twente in Enschede.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who undergoing an elective coronary procedure at Thoraxcenteum Twente in the period of June 2014 until August 2014\n\nExclusion Criteria:\n\n* Language barrier'}, 'identificationModule': {'nctId': 'NCT02625493', 'acronym': 'PREVAS', 'briefTitle': 'Patient Preference for Radial Versus Femoral Vascular Access', 'organization': {'class': 'OTHER', 'fullName': 'Thorax Centrum Twente'}, 'officialTitle': 'Patient Preferences for Radial Versus Femoral Vascular Access Options by Coronary Angiography and Intervention', 'orgStudyIdInfo': {'id': 'Prevas-v2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'study population', 'description': 'All patients who underwent elective coronary procedures belonged to the one group, they received standard care without any additional interventions, but were asked to fill in a questionnaire.', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'Questionnaire containing a Best-worst Scaling scenario', 'armGroupLabels': ['study population']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Enschede', 'country': 'Netherlands', 'facility': 'Medisch Spectrum Twente', 'geoPoint': {'lat': 52.21833, 'lon': 6.89583}}], 'overallOfficials': [{'name': 'Harald Verheij', 'role': 'STUDY_DIRECTOR', 'affiliation': 'research manager'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thorax Centrum Twente', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation of Cardiovascular Research and Education Enschede', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Clemens von Birgelen', 'investigatorAffiliation': 'Thorax Centrum Twente'}}}}