Ignite Creation Date:
2025-12-24 @ 9:36 PM
Ignite Modification Date:
2026-04-04 @ 5:35 PM
Study NCT ID:
NCT00841932
Status:
COMPLETED
Last Update Posted:
2009-02-12
First Post:
2009-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053805', 'term': 'Fractional Flow Reserve, Myocardial'}], 'ancestors': [{'id': 'D003326', 'term': 'Coronary Circulation'}, {'id': 'D001775', 'term': 'Blood Circulation'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-02-11', 'studyFirstSubmitDate': '2009-02-06', 'studyFirstSubmitQcDate': '2009-02-11', 'lastUpdatePostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications related to use of pressure wire', 'timeFrame': '0-30 days (index procedure)'}], 'secondaryOutcomes': [{'measure': 'Complications due to FFR procedure', 'timeFrame': '0-30 days (index hospitalization)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Fractional Flow Reserve', 'Without anticoagulation'], 'conditions': ['Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety of performing fractional flow reserve (FFR) of the myocardium without using anticoagulation by performing a retrospective review of 100 consecutive patients who have undergone this procedure during diagnostic catheterization.', 'detailedDescription': 'An experienced interventional cardiologist can perform FFR in a brief period of time. This procedure can safely be performed without anticoagulation, thereby lowering the associated procedural risks by avoiding the bleeding and groin complications that may occur with anticoagulation. Performing FFR without anticoagulation may also decrease facility costs as femoral artery closure can be performed using standard protocols for a diagnostic procedure, instead of standard protocols for an interventional procedure when a patient has been anticoagulated. Performing FFR without anticoagulation does not increase risk of injury to the coronary artery or thrombus in the coronary artery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent fractional flow reserve (FFR) by Dr. Jonathan Roberts without anticoagulation during diagnostic catheterization were included in this registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with moderate stenosis who underwent FFR without anticoagulation\n\nExclusion Criteria:\n\n* Therapeutic anticoagulation'}, 'identificationModule': {'nctId': 'NCT00841932', 'briefTitle': 'Performing Fractional Flow Reserve Without Anticoagulation During Diagnostic Catheterization', 'organization': {'class': 'OTHER', 'fullName': 'Clinyx, LLC'}, 'officialTitle': 'Retrospective Assessment of the Safety of Performing Fractional Flow Reserve (FFR) of the Myocardium Without Anticoagulation During Diagnostic Cardiac Catheterization', 'orgStudyIdInfo': {'id': 'CL-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fractional Flow Reserve', 'description': 'Patients with suspected coronary artery disease undergoing FFR to assess physiological significance of stenosis', 'interventionNames': ['Procedure: Fractional Flow Reserve']}], 'interventions': [{'name': 'Fractional Flow Reserve', 'type': 'PROCEDURE', 'description': 'Fractional Flow Reserve performed without anticoagulation', 'armGroupLabels': ['Fractional Flow Reserve']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jonathan Roberts, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinyx, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinyx, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Volcano Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Holly Taylor, VP', 'oldOrganization': 'Clinyx'}}}}