Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-07 @ 10:35 AM
Study NCT ID:
NCT02685995
Status:
COMPLETED
Last Update Posted:
2021-02-08
First Post:
2016-01-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gregory.nadolski@pennmedicine.upenn.edu', 'phone': '(215) 662-7892', 'title': 'Gregory Nadolski, MD', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '90 days from enrollment', 'description': 'No adverse events occurred in this study', 'eventGroups': [{'id': 'EG000', 'title': 'Palindrome TDC', 'description': 'TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'VectorFlow TDC', 'description': 'TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 0, 'seriousNumAtRisk': 50, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Patency - Intervention-free Interval (Measured in Weeks)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Palindrome TDC', 'description': 'TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.'}, {'id': 'OG001', 'title': 'VectorFlow TDC', 'description': 'TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.'}], 'classes': [{'title': '30 Days', 'categories': [{'measurements': [{'value': '89.1', 'spread': '6.2', 'groupId': 'OG000'}, {'value': '95.5', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': '60 Days', 'categories': [{'measurements': [{'value': '79.4', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '87.2', 'spread': '7.3', 'groupId': 'OG001'}]}]}, {'title': '90 days', 'categories': [{'measurements': [{'value': '71.5', 'spread': '12.6', 'groupId': 'OG000'}, {'value': '80.6', 'spread': '9.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '30, 60 and 90 days', 'description': 'The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow \\>300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure.', 'unitOfMeasure': 'percentage of primary patency', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Palindrome TDC', 'description': 'TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.'}, {'id': 'FG001', 'title': 'VectorFlow TDC', 'description': 'TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '50'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Insertion of immediately puncturable graft.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Palindrome TDC', 'description': 'TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.'}, {'id': 'BG001', 'title': 'VectorFlow TDC', 'description': 'TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'BG000', 'lowerLimit': '49', 'upperLimit': '67'}, {'value': '59', 'groupId': 'BG001', 'lowerLimit': '46', 'upperLimit': '69'}, {'value': '58', 'groupId': 'BG002', 'lowerLimit': '46', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '100', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ESRD patients receiving tunneled dialysis catheters'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-10', 'size': 654597, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-01-12T15:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-20', 'studyFirstSubmitDate': '2016-01-15', 'resultsFirstSubmitDate': '2021-01-20', 'studyFirstSubmitQcDate': '2016-02-18', 'lastUpdatePostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-01-20', 'studyFirstPostDateStruct': {'date': '2016-02-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Patency - Intervention-free Interval (Measured in Weeks)', 'timeFrame': '30, 60 and 90 days', 'description': 'The primary study endpoint will be primary patency at 90 days following catheter insertion. Primary patency is defined as an HD catheter which provides adequate hemodialysis (flow \\>300mL/min) without need for additional interventions (ie TPA infusions or catheter exchange) to maintain flow or correct device failure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Renal Failure Chronic Requiring Hemodialysis', 'Chronic Renal Insufficiency']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.teleflex.com/en/usa/productAreas/interventionalAccess/productGroups/chronic-hemodialysis/products/vector/', 'label': 'Vectorlow Dialysis Catheter Product Information'}]}, 'descriptionModule': {'briefSummary': 'Randomized two-arm study examining 90 day primary patency of two FDA-approved tunneled dialysis catheters.', 'detailedDescription': 'The VectorFlow tunneled dialysis catheter is a novel symmetrical tip design tunneled dialysis catheter which in pre-clinical testing and retrospective review has improved flow and patency compared to other dialysis catheter designs. This study will compare 90 day patency rates of newly inserted VF catheters to the Palindrome catheter both of which are FDA approved devices and will inserted as standard of care. The Palindrome catheter has been selected as the comparison device because it is also a symmetrical tip catheter design and prior studies by the manufacturer of this device suggests it has a lower occlusion rate and better flow compared to other catheter designs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* End stage renal disease or acute renal failure requiring hemodialysis through a tunneled dialysis catheter\n* Age \\>18, Age \\<80\n* Capable of giving informed consent\n\nExclusion Criteria:\n\n* Coagulopathy defined as international normalized ration (INR) \\>2 which cannot be corrected with fresh frozen plasma\n* Platelet count \\<50,000/microliter, which cannot be corrected with platelet transfusion\n* Active skin infections at site of TDC insertion\n* Presence of bacteremia or infected AVG/AVF within 7 days prior to enrollment\n* Neutropenia defined as absolute neutrophil count less then 1,700/microliter\n* Known central venous stenosis\n* Occlusion of bilateral external and internal jugular veins or bilateral brachiocephalic veins or stenosis of the superior vena cava\n* Functioning surgical HD access (ie AVG/AVF) or AVG/AVF which is expected to be functional within 90 days of enrollment\n* Inability to provide informed consent\n* Pregnant or nursing women\n* In the event a physician does not feel that either catheter would be appropriate for a subject, the subject will not be eligible to participate'}, 'identificationModule': {'nctId': 'NCT02685995', 'acronym': 'TDC', 'briefTitle': 'VectorFlow Tunneled Dialysis Catheter (TDC) Versus Palindrome TDC', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Randomized Trial Comparing VectorFlow Tunneled Dialysis Catheter to Palindrome Tunneled Dialysis Catheter', 'orgStudyIdInfo': {'id': '823055'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Palindrome TDC', 'description': 'TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.', 'interventionNames': ['Device: Palindrome TDC']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'VectorFlow TDC', 'description': 'TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.', 'interventionNames': ['Device: VectorFlow TDC']}], 'interventions': [{'name': 'VectorFlow TDC', 'type': 'DEVICE', 'otherNames': ['ARROW-Clark™ VectorFlow™ Hemodialysis Catheter'], 'description': 'TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.', 'armGroupLabels': ['VectorFlow TDC']}, {'name': 'Palindrome TDC', 'type': 'DEVICE', 'otherNames': ['Palindrome™ Dialysis Catheter'], 'description': 'TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.', 'armGroupLabels': ['Palindrome TDC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the Unviersity of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn Presbyterian Medical Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Gregory Nadolski, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teleflex', 'class': 'INDUSTRY'}, {'name': 'Arrow International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}