Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT02136004
Status:
COMPLETED
Last Update Posted:
2017-10-27
First Post:
2014-05-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'scwong@med.cornell.edu', 'phone': '212-746-4644', 'title': 'S. Chiu Wong, MD', 'organization': 'Weill Cornell Medical College'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.', 'otherNumAtRisk': 220, 'otherNumAffected': 12, 'seriousNumAtRisk': 220, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Non-serious access site bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Serious device-related adverse events, excluding endpoint events', 'stats': [{'groupId': 'EG000', 'numAtRisk': 220, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Hemostasis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.78', 'groupId': 'OG000', 'lowerLimit': '0.74', 'upperLimit': '2.82'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'procedural, usually within 15 minutes of enrollment', 'description': 'Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled'}, {'type': 'PRIMARY', 'title': 'Rate of Combined Major Access Site Closure-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through 30 days +/- 7 days', 'description': 'Primary safety endpoint - rate of combined major access site closure-related complications', 'unitOfMeasure': 'complications', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled'}, {'type': 'SECONDARY', 'title': 'Time to Ambulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '2.36', 'upperLimit': '2.64'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to hospital discharge, usually within 24 hours', 'description': 'Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled'}, {'type': 'SECONDARY', 'title': 'Time to Discharge Eligibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.83', 'groupId': 'OG000', 'lowerLimit': '2.62', 'upperLimit': '3.03'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'prior to hospital discharge, usually within 24 hours', 'description': "Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)", 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled'}, {'type': 'SECONDARY', 'title': 'Time to Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.12', 'groupId': 'OG000', 'lowerLimit': '10.93', 'upperLimit': '15.32'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'through hospital discharge, usually within 24 hours', 'description': 'Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward', 'unitOfMeasure': 'hours', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled'}, {'type': 'SECONDARY', 'title': 'Device Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '216', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'procedural, usually within 15 minutes of enrollment', 'description': 'Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled'}, {'type': 'SECONDARY', 'title': 'Rate of Combined Minor Access Site Closure-related Complications', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through 30 +/- 7 days', 'description': 'Secondary safety endpoint - rate of combined minor access site closure-related complications', 'unitOfMeasure': 'complications', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled'}, {'type': 'SECONDARY', 'title': 'Procedure Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '219', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}], 'classes': [{'categories': [{'measurements': [{'value': '219', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'through 30 days +/- 7 days', 'description': 'Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects enrolled.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy\n\nCloser VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Enrollment commenced on May 20, 2014 and the last subject completed follow-up on February 28, 2015', 'groupId': 'FG000', 'numSubjects': '220'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '220', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Closer VSS - Diagnostic Cohort', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in diagnostic endovascular cases.\n\nCloser VSS: At the end of a percutaneous diagnostic endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}, {'id': 'BG001', 'title': 'Closer VSS - Interventional Cohort', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in interventional endovascular cases.\n\nCloser VSS: At the end of a percutaneous interventional endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '10.3', 'groupId': 'BG000'}, {'value': '64.7', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '63.9', 'spread': '9.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '150', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 220}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-26', 'studyFirstSubmitDate': '2014-05-07', 'resultsFirstSubmitDate': '2016-11-01', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-11-01', 'studyFirstPostDateStruct': {'date': '2014-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Hemostasis', 'timeFrame': 'procedural, usually within 15 minutes of enrollment', 'description': 'Primary effectiveness endpoint - elapsed time between the Closer VSS delivery system removal and first observed and confirmed arterial hemostasis'}, {'measure': 'Rate of Combined Major Access Site Closure-related Complications', 'timeFrame': 'Through 30 days +/- 7 days', 'description': 'Primary safety endpoint - rate of combined major access site closure-related complications'}], 'secondaryOutcomes': [{'measure': 'Time to Ambulation', 'timeFrame': 'prior to hospital discharge, usually within 24 hours', 'description': 'Secondary efficacy endpoint - elapsed time between the Closer VSS delivery system removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding from the access site'}, {'measure': 'Time to Discharge Eligibility', 'timeFrame': 'prior to hospital discharge, usually within 24 hours', 'description': "Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject's access site is assessed to be hemodynamically stable, as determined by the investigator or his/her designee(s)"}, {'measure': 'Time to Hospital Discharge', 'timeFrame': 'through hospital discharge, usually within 24 hours', 'description': 'Secondary efficacy endpoint - elapsed time between Closer VSS delivery system removal and when subject is actually physically discharged from the hospital ward'}, {'measure': 'Device Success', 'timeFrame': 'procedural, usually within 15 minutes of enrollment', 'description': 'Secondary efficacy endpoint - the ability to deploy the system, deliver the implant, and achieve arterial hemostasis with the Closer VSS alone or with post-hemostasis adjunctive compression'}, {'measure': 'Rate of Combined Minor Access Site Closure-related Complications', 'timeFrame': 'through 30 +/- 7 days', 'description': 'Secondary safety endpoint - rate of combined minor access site closure-related complications'}, {'measure': 'Procedure Success', 'timeFrame': 'through 30 days +/- 7 days', 'description': 'Secondary efficacy endpoint - attainment of final arterial hemostasis using any method and freedom from major access site closure-related complications through 30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['arteriotomy', 'vessel closure', 'femoral access site'], 'conditions': ['Surgical Wound']}, 'descriptionModule': {'briefSummary': 'The objective of this trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System in sealing femoral arterial access sites.', 'detailedDescription': 'The objective of the trial is to demonstrate the safety and effectiveness of the Rex Medical Closer Vascular Sealing System (VSS) in sealing femoral arterial access sites and providing reduced times to hemostasis (TTH) compared with performance goals at the completion of diagnostic or interventional procedures performed through 5, 6 or 7 Fr procedural sheaths. This study will be considered a success (from a statistical perspective) if it meets both the Closer VSS superiority goal for the primary effectiveness analysis and the Closer VSS performance goal for the primary safety analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPre-Op Inclusion Criteria:\n\n1 - Acceptable candidates for an elective, non-emergent diagnostic or interventional endovascular procedure via the common femoral artery using a 5, 6, or 7 Fr introducer sheath.\n\n\\-\n\nExclusion Criteria:\n\nPre-Operative Exclusion Criteria:\n\n1. \\- Significant bleeding diatheses or coagulopathy\n2. \\- Planned endovascular or surgical procedures within next 30 days\n3. \\- Planned ipsilateral femoral arteriotomy within next 90 days\n4. \\- Arteriotomy in ipsilateral groin within the past 30 days with any residual hematoma, significant bruising or vascular complication\n5. \\- Previous vessel closure device used in ipsilateral groin within the past 90 days\n6. \\- Previous vascular surgery or repair in the vicinity of the target access site\n7. \\- Severe peripheral vascular disease in the ipsilateral limb requiring surgical or endovascular treatment within the pervious 30 days or next 30 days\n8. \\- Existing nerve damage in ipsilateral limb\n9. \\- Extreme morbid obesity (BMI \\> 4 kg/m2)\n\n Intra-operative Exclusion Criteria:\n10. \\- Use of a procedural sheath that is \\< 5 Fr or \\> 7 Fr\n11. \\- Difficult insertion of procedural sheath or needle stick problems at the onset of the procedure\n12. \\- Placement of an ipsilateral venous sheath for procedure\n13. \\- Procedural sheath placement either through the superficial femoral artery and into the profunda femoris artery, or placement at or distal to bifurcation of the superficial femoral artery and the profunda femoris artery\n14. \\- In subjects receiving unfractionated heparin, an ACT \\> 350 seconds, or \\> 250 seconds in the presence of a GP IIb/IIIa inhibitor\n15. \\- Procedures or existing medical conditions that may extend index hospitalization beyond 24 hours post-procedure\n16. \\- Systemic hypertension (SBP \\> 180 mmHg) or hypotension (SBP \\< 90 mmHg) just prior to enrollment'}, 'identificationModule': {'nctId': 'NCT02136004', 'acronym': 'Closer', 'briefTitle': 'The Closer Trial: A Safety and Efficacy Study of the Rex Medical Vascular Sealing System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rex Medical'}, 'officialTitle': 'The Closer Trial: A Multi-center, Prospective, Single Arm Trial to Evaluate the Safety and Efficacy of the Rex Medical Closer Vascular Sealing System (VSS) for the Management of the Femoral Arteriotomy After Percutaneous Endovascular Procedures', 'orgStudyIdInfo': {'id': 'REX-US-2027-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Closer VSS', 'description': 'Rex Medical Closer Vascular Sealing System to close femoral arteriotomy', 'interventionNames': ['Device: Closer VSS']}], 'interventions': [{'name': 'Closer VSS', 'type': 'DEVICE', 'otherNames': ['Rex Medical Closer TM Vascular Sealing System (VSS)'], 'description': 'At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.', 'armGroupLabels': ['Closer VSS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Neurological Institute', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '20010', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '70503', 'city': 'Lafayette', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Lafayette General Medical Center/Cardiovascular Institute of the South', 'geoPoint': {'lat': 30.22409, 'lon': -92.01984}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44035', 'city': 'Elyria', 'state': 'Ohio', 'country': 'United States', 'facility': 'North Ohio Research', 'geoPoint': {'lat': 41.36838, 'lon': -82.10765}}, {'zip': '74104', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Heart Institute', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17822', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Health Center', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '18711', 'city': 'Wilkes-Barre', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Health Center', 'geoPoint': {'lat': 41.24591, 'lon': -75.88131}}, {'zip': '17043', 'city': 'Wormleysburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Pinnacle Health', 'geoPoint': {'lat': 40.26287, 'lon': -76.91386}}, {'zip': '78756', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Heart Hospital of Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Shing-Chiu Wong, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'New York Presbyterian Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'After multi-center manuscript is published.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rex Medical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}