Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-29 @ 11:55 PM
Study NCT ID:
NCT05859503
Status:
UNKNOWN
Last Update Posted:
2023-05-17
First Post:
2023-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-16', 'studyFirstSubmitDate': '2023-05-03', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of Major vascular complications', 'timeFrame': '30 days', 'description': 'Incidence of patients with Major vascular complications'}, {'measure': 'Assessment of Major vascular complications', 'timeFrame': 'Discharge (assessed up to day 5)', 'description': 'Incidence of patients with Major vascular complications'}, {'measure': 'Assessment of rebleeding', 'timeFrame': 'Discharge (assessed up to day 5)', 'description': 'Incidence of patients with rebleeding'}, {'measure': 'Rebleeding', 'timeFrame': '30 days', 'description': 'Incidence of patients with rebleeding'}], 'secondaryOutcomes': [{'measure': 'Assessment of Death', 'timeFrame': 'Discharge (assessed up to day 5)', 'description': 'Incidence of dead patients'}, {'measure': 'Assessment of Death', 'timeFrame': '30 days', 'description': 'Incidence of dead patients'}, {'measure': 'Assessment of Death related to vascular access', 'timeFrame': '30 days', 'description': 'Incidence of dead patients related to vascular access'}, {'measure': 'Assessment of Death related to vascular access', 'timeFrame': 'Discharge (assessed up to day 5)', 'description': 'Incidence of dead patients related to vascular access'}, {'measure': 'Assessment of Hematoma', 'timeFrame': '24 hours', 'description': 'Incidence of patients with hematoma the venous puncture'}, {'measure': 'Assessment of Hematoma Size', 'timeFrame': '24 hours', 'description': 'Area in cm of the hematoma at the venous puncture in patients with hematoma'}, {'measure': 'Assessment of Vascular access point infection', 'timeFrame': 'Discharge (assessed up to day 5)', 'description': 'Incidence of patients with infection in vascular access point'}, {'measure': 'Assessment of Vascular access point infection', 'timeFrame': '30 days', 'description': 'Incidence of patients with infection in vascular access point'}, {'measure': 'Assessment of Urinary infections', 'timeFrame': '30 days', 'description': 'Incidence of patients with urinary infection'}, {'measure': 'Assessment of Urinary infections', 'timeFrame': 'Discharge (assessed up to day 5)', 'description': 'Incidence of patients with urinary infection'}, {'measure': 'Assessment of sitting-walking time', 'timeFrame': 'Discharge (assessed up to day 5)', 'description': 'Time in hours between the patient sitting and walking after the vascular access'}, {'measure': 'Assessment of Technical success', 'timeFrame': '1 minute after closure performed', 'description': 'Technical success when complete hemostasis is less than 1 minute after closure strategy performed'}, {'measure': 'Assessment of Clinical success', 'timeFrame': 'Discharge (assessed up to day 5)', 'description': 'Technical success in the absence of events after closure strategy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Femoral venous access closure techniques', 'Figure-of-8 suture,Perclose-Proglide system'], 'conditions': ['Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '22431302', 'type': 'BACKGROUND', 'citation': 'Hamid T, Rajagopal R, Pius C, Clarke B, Mahadevan VS. Preclosure of large-sized venous access sites in adults undergoing transcatheter structural interventions. Catheter Cardiovasc Interv. 2013 Mar;81(4):586-90. doi: 10.1002/ccd.24358. Epub 2012 Nov 8.'}, {'pmid': '32308550', 'type': 'BACKGROUND', 'citation': 'Jensen CJ, Schnur M, Lask S, Attanasio P, Gotzmann M, Kara K, Hanefeld C, Mugge A, Wutzler A. Feasibility of the Figure-of-8-Suture as Venous Closure in Interventional Electrophysiology: One Strategy for All? Int J Med Sci. 2020 Apr 6;17(7):965-969. doi: 10.7150/ijms.42593. eCollection 2020.'}, {'pmid': '30726903', 'type': 'BACKGROUND', 'citation': 'Mohanty S, Trivedi C, Beheiry S, Al-Ahmad A, Horton R, Della Rocca DG, Gianni C, Gasperetti A, Abdul-Moheeth M, Turakhia M, Natale A. Venous access-site closure with vascular closure device vs. manual compression in patients undergoing catheter ablation or left atrial appendage occlusion under uninterrupted anticoagulation: a multicentre experience on efficacy and complications. Europace. 2019 Jul 1;21(7):1048-1054. doi: 10.1093/europace/euz004.'}, {'pmid': '28303670', 'type': 'BACKGROUND', 'citation': 'Pracon R, Bangalore S, Henzel J, Cendrowska-Demkow I, Pregowska-Chwala B, Tarnowska A, Dzielinska Z, Chmielak Z, Witkowski A, Demkow M. A randomized comparison of modified subcutaneous "Z"-stitch versus manual compression to achieve hemostasis after large caliber femoral venous sheath removal. Catheter Cardiovasc Interv. 2018 Jan 1;91(1):105-112. doi: 10.1002/ccd.27003. Epub 2017 Mar 17.'}, {'pmid': '24694560', 'type': 'BACKGROUND', 'citation': 'Geis NA, Pleger ST, Chorianopoulos E, Muller OJ, Katus HA, Bekeredjian R. Feasibility and clinical benefit of a suture-mediated closure device for femoral vein access after percutaneous edge-to-edge mitral valve repair. EuroIntervention. 2015 Mar;10(11):1346-53. doi: 10.4244/EIJV10I11A231.'}, {'pmid': '30146036', 'type': 'BACKGROUND', 'citation': 'Noori VJ, Eldrup-Jorgensen J. A systematic review of vascular closure devices for femoral artery puncture sites. J Vasc Surg. 2018 Sep;68(3):887-899. doi: 10.1016/j.jvs.2018.05.019. Epub 2018 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to compare the efficacy and safety of two strategies for closing large caliber venous access in patients undergoing percutaneous procedures: compression with figure-of-8 suture versus closure with the Perclose-Proglide system.', 'detailedDescription': "This is a retrospective observational study that aims to compare two strategies for closing large-caliber femoral venous access in patients who have undergone percutaneous procedures.\n\nThe study's goal is to determine if there are significant differences in terms of efficacy and safety between the two closure strategies. Figure-of-8 suture compression is a well-established technique that has been used for decades to close large-bore femoral venous access, while the Perclose-Proglide system is a relatively new medical device that could have great utility for the closure of large-bore femoral venous access. By comparing these two strategies, researchers hope to determine the safety and effectiveness of the Perclose-Proglide system for closing large-bore femoral venous access in patients undergoing percutaneous procedures."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have undergone interventional procedures and who have required the use of figure-of-8 suture versus Perclose-Proglide system closure', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients will meet all inclusion criteria:\n\n* Adult patients aged \\> 18 years\n* Patients who have undergone percutaneous interventional procedures\n* Patients in whom the procedures have been performed with femoral venous access\n* Patients who have required large caliber pods ≥ 14 French.\n\nExclusion Criteria:\n\nPatients must not meet any exclusion criteria:\n\n* Patients who have required access with surgical exposure.\n* Patients who have required ipsilateral arterial access with a large caliber ≥ 14 French\n* Patients with previous vascular surgery.'}, 'identificationModule': {'nctId': 'NCT05859503', 'briefTitle': 'A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access.', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'A Comparison Study of the Perclose Proglide (TM) SMC System Versus Figure-of-8- Suture Technique for Closure of Large-bore Femoral Venous Access. (PERCLOSE-PROGLIDE)', 'orgStudyIdInfo': {'id': 'PERCLOSE PROGLIDE'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Perclose-Proglide system', 'interventionNames': ['Other: Closure Strategy with Perclose-Proglide system']}, {'label': 'Figure-of-8', 'interventionNames': ['Other: Closure Strategy with figure-of-8']}], 'interventions': [{'name': 'Closure Strategy with Perclose-Proglide system', 'type': 'OTHER', 'description': 'Patients who have required Perclose-Proglide system in Percutaneous Interventional Procedure', 'armGroupLabels': ['Perclose-Proglide system']}, {'name': 'Closure Strategy with figure-of-8', 'type': 'OTHER', 'description': 'Patients who have required the manual compression with figure-of-8 in Percutaneous Interventional Procedure', 'armGroupLabels': ['Figure-of-8']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'facility': "Hospital Universitari Vall D'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'BRUNO GARCIA DEL BLANCO, PhD, MD', 'role': 'CONTACT', 'email': 'brunogb51@gmail.com', 'phone': '0034932746135'}, {'name': 'MARIA ANGELES CARMONA', 'role': 'CONTACT', 'email': 'm.angeles.carmona@vhir.org', 'phone': '0034932746135'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}