Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2025-12-26 @ 2:43 AM
Study NCT ID:
NCT07246902
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-11-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mobilization and Outcomes After Venous Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '14 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2025-11-13', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Time to Ambulation', 'timeFrame': 'From end of index procedure until time before hospital discharge (usually within ~24 hours of procedure)', 'description': 'Defined as elapsed time (in hours) between removal of the final MCV VCD and when subject stands and walks 20 feet without evidence of rebleeding from any femoral venous access site.'}, {'measure': 'Time to Discharge', 'timeFrame': 'From end of index procedure until time of hospital discharge (usually within ~24 hours of procedure)', 'description': 'Defined as the elapsed time (in minutes) between removal of the final MCV VCD and when the subject is discharged from the hospital, as recorded on the discharge order.'}, {'measure': 'Time to Hemostasis', 'timeFrame': 'From time of index procedure until time before hospital discharge (usually within ~24 hours of procedure)', 'description': 'Defined as elapsed time (in minutes) between removal of each MCV VCD and first observed and confirmed venous hemostasis (per access site analysis).'}, {'measure': 'SDD sustained MCV VCD success', 'timeFrame': 'From end of index procedure through 14 days post-procedure', 'description': 'Defined as the proportion of subjects who did not require hospital intervention within 14 days post-procedure due to access site-related complications'}, {'measure': 'Device success evaluated at the end of the procedure', 'timeFrame': 'End of index procedure', 'description': 'Defined as the ability to deploy the delivery system and deliver the PEG component to achieve hemostasis at each access site'}, {'measure': 'Procedural Success', 'timeFrame': 'From end of index procedure through 14 days post-procedure', 'description': 'Defined as the attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 14 days'}, {'measure': 'Procedural Time', 'timeFrame': 'Index procedure', 'description': 'Defined as time of first sheath insertion until the time of removal of final MCV VCD.'}, {'measure': 'Recovery room time', 'timeFrame': 'From time of transfer to recovery room post-discharge to time of discharge (usually within ~24 hours of procedure)', 'description': 'Defined as elapsed time (in minutes) between when the subject is transferred to recovery and when the subject is discharged from the hospital, as recorded on the discharge order.'}, {'measure': 'Analysis of Cost Effectiveness - Comprehensive summary of clinical outcomes, resource utilization, economic proxies, patients reported outcomes and CPT codes', 'timeFrame': 'From start time of index procedure through 14 days post-procedure', 'description': 'An analysis of cost effectiveness will be performed based on a summary of key clinical outcomes, resource utilization, economic proxies, patients reported outcomes and CPT codes'}, {'measure': 'Incidence of urinary catheter usage', 'timeFrame': 'From start time of index procedure through end time of index procedure', 'description': 'Number/rate of patients with urinary catheters used during the procedure'}, {'measure': 'Rate of protamine usage', 'timeFrame': 'From start time of index procedure through end time of index procedure', 'description': 'Rate of protamine usage during the procedure'}, {'measure': 'Medication Usage', 'timeFrame': 'From pre-procedure though study exit/follow-up visit (14 +/- 7 days post-procedure)', 'description': 'Rate of patients who are administered anti-platelet, anti-coagulant, anti-thrombotic, local anesthetic, protamine or pain medication)'}], 'primaryOutcomes': [{'measure': 'Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications', 'timeFrame': 'From time of index procedure through end of following day (within 48 hours)', 'description': 'Rate of patients who successfully received a study device at all access sites and had SDD without subsequent hospitalization/intervention for access-site complications either same day post-discharge or the next day'}, {'measure': 'Rate of access-site complications', 'timeFrame': 'From time of study device introduction at first access site through 14 days post-procedure', 'description': 'Rate of access-site complications, assessed per standard of care, through 14 days post-procedure, including:\n\n* Access Site-Related Hematoma \\> 6 cm documented by ultrasound\n* Local Access Site Infection confirmed by culture and sensitivity, treated with intramuscular or oral antibiotics\n* Allergic Reaction\n* Access site-related bleeding requiring transfusion, surgical intervention, or rehospitalization\n* Pulmonary embolism requiring surgical or endovascular intervention and/or resulting in death, to be confirmed by CT pulmonary angiography, lung ventilation/perfusion scan (VQ scan), or autopsy\n* DVT requiring pharmaceutical or surgical intervention'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Electrophysiology Study', 'Venous closure', 'Venous access closure', 'Vascular access closure', 'Venous Vascular Closure', 'Vascular closure device', 'MYNX CONTROL VENOUS', 'MOVE Registry', 'MOVE', 'Cardiac Catheterization', 'MYNX'], 'conditions': ['Venous Vascular Closure', 'Electrophysiology Study']}, 'descriptionModule': {'briefSummary': 'The primary objective of this post-market registry is to collect real-world outcomes and evaluate usage practice of MYNX CONTROL™ VENOUS (MCV) Vascular Closure Device (VCD) 6F-12F in sealing femoral venous access sites in patients who have undergone endovascular procedures in a real-world setting.', 'detailedDescription': 'The study is a single-arm, prospective, multi-center, observational, real-world registry of venous access site closures utilizing MYNX CONTROL™ VENOUS VCD 6F-12F following endovascular procedures. The study will enroll approximately 300 subjects in approximately 15 study sites in the United States.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study includes patients who undergo catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs, and have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n1. Able and willing to provide informed consent and to complete a follow-up visit at 14 ± 7 days post-procedure.\n2. Individuals undergoing catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs.\n3. Individuals who are candidates to have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.\n4. At the time of enrollment, the Investigator deems the subject a candidate for same-day discharge (SDD) per standard of care (no procedure related events/complications e.g., no new pericardial effusion, post-procedure diuresis not needed, etc.).\n\nExclusion Criteria\n\n1. Presence of bruit, palpable aneurysm, significant candida or groin infection.\n2. Prior to closure, presence of hematoma in the accessed limb.\n3. Currently involved in any other clinical trial that may interfere with the outcomes of this study as determined by the Investigator.\n4. Planned use of other closure devices or techniques other than MYNX CONTROL™ VENOUS VCD 6F-12F.\n5. Life expectancy \\<12 months.'}, 'identificationModule': {'nctId': 'NCT07246902', 'acronym': 'MOVE', 'briefTitle': 'Mobilization and Outcomes After Venous Closure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cordis US Corp.'}, 'officialTitle': 'MOVE - Mobilization and Outcomes After VEnous Closure - A Prospective Registry of Real-World Outcomes/Usage/Evidence for the MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F', 'orgStudyIdInfo': {'id': 'P25-8302'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MCV VCD Treatment', 'description': 'Subjects who undergo catheter-based procedures utilizing 6F to 12F inner diameter procedural sheaths, with single or multiple venous access sites in one or both limbs, and have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.', 'interventionNames': ['Device: MYNX CONTROLTM VENOUS Vascular Closure Device']}], 'interventions': [{'name': 'MYNX CONTROLTM VENOUS Vascular Closure Device', 'type': 'DEVICE', 'description': 'The MYNX CONTROLTM VENOUS (MCV) Vascular Closure Device (VCD) 6F-12F is indicated for use to seal femoral venous access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing 6F to 12F procedural sheaths, with single or multiple access sites in one or both limbs.\n\nMCV VCD is designed to achieve femoral vein hemostasis via delivery of the GRIP TECHNOLOGY™ sealant (an extravascular, water-soluble synthetic hydrogel), using a balloon catheter in conjunction with a standard procedural sheath. The sealant is made of a polyethylene glycol (PEG) material which expands upon contact with subcutaneous fluids to seal the venotomy and is resorbed by the body within 30 days.\n\nThe MCV VCD is supplied with a 10ml locking syringe used for balloon inflation and deflation. The catheter shaft has a silicone lubricant to facilitate insertion and withdrawal into compatible sheaths.', 'armGroupLabels': ['MCV VCD Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dhanunjaya Lakkireddy, MD', 'role': 'CONTACT', 'email': 'dhanunjaya.lakkireddy@hcahealthcare.com'}, {'name': 'Donita Atkins', 'role': 'CONTACT', 'email': 'donita.atkins@hcahealthcare.com'}], 'facility': 'KC Heart and Rhythm Institute', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'centralContacts': [{'name': 'Rajesh Nathan', 'role': 'CONTACT', 'email': 'rajesh.nathan@cordis.com', 'phone': '908-528-3931'}, {'name': 'Jennifer Lee', 'role': 'CONTACT', 'email': 'jennifer.lee02@cordis.com', 'phone': '559-307-7753'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cordis US Corp.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'NAMSA', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}