Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-02-22 @ 4:53 PM
Study NCT ID:
NCT02339857
Status:
COMPLETED
Last Update Posted:
2015-01-16
First Post:
2015-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Long-term Results of the No-touch Vein Graft to the Left Anterior Descending Artery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'lastUpdateSubmitDate': '2015-01-15', 'studyFirstSubmitDate': '2015-01-12', 'studyFirstSubmitQcDate': '2015-01-15', 'lastUpdatePostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total patency of the no-touch vein grafts.', 'timeFrame': 'Mean time 8 years.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['coronary artery bypass grafting', 'saphenous vein', 'grafts'], 'conditions': ['Ischemic Heart Disease', 'Atherosclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients that performed coronary artery bypass surgery between 2003-2008 and received a no-touch saphenous vein graft to the left anterior descending artery were included consecutively.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Coronary artery bypass grafting performed at the Department of Cardiothoracic Surgery, Örebro Universtiy Hospital between 2003-2008.\n2. Saphenous vein graft harvesting using the no-touch technique.\n3. The saphenous vein anastomised to the left anterior descending artery.\n4. Informed consent\n\nExclusion Criteria:\n\n1. Allergy to contrast media.\n2. Impaired renal function.\n3. Inability to conduct the study according to protocol.'}, 'identificationModule': {'nctId': 'NCT02339857', 'briefTitle': 'The Long-term Results of the No-touch Vein Graft to the Left Anterior Descending Artery.', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Örebro County Council'}, 'officialTitle': 'The Long-term Results of Coronary Artery Bypass Surgery When the No-touch Vein Graft is Anastomised to the Left Anterior Descending Artery.', 'orgStudyIdInfo': {'id': '102881'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No-touch vein grafts to LAD', 'interventionNames': ['Procedure: No-touch harvesting technique']}], 'interventions': [{'name': 'No-touch harvesting technique', 'type': 'PROCEDURE', 'description': 'The saphenous vein is harvested with a pedicle of surrounding tissue.', 'armGroupLabels': ['No-touch vein grafts to LAD']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ninos Samano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine and Health, Örebro University, Örebro, Sweden'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Örebro County Council', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Cardiothoracic surgeon', 'investigatorFullName': 'Ninos Samano M.D.', 'investigatorAffiliation': 'Örebro University, Sweden'}}}}