[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611924":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":30,"responsibleParty":85,"collaborators":87,"id":91,"slug":92,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":10,"maxAge":10,"enrollmentInfo":100,"targetDuration":103,"studyType":104,"phases":10,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":33,"whyStopped":10,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":127},{"fullName":5,"class":6},"Cordis US Corp.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MCV VCD Treatment",null,"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.",[13],"Device: MYNX CONTROLTM VENOUS Vascular Closure Device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","MYNX CONTROLTM VENOUS Vascular Closure Device","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.",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Rajesh Nathan","CONTACT","908-528-3931","rajesh.nathan@cordis.com",{"name":27,"role":23,"phone":28,"phoneExt":10,"email":29},"Jennifer Lee","559-307-7753","jennifer.lee02@cordis.com",[31,53,69],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"South Denver Cardiology","RECRUITING","Littleton","Colorado","80210","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-105.01665,39.61332,{"lat":43,"lon":42},[46,50],{"name":47,"role":23,"phone":10,"phoneExt":48,"email":49},"Kathy Siegel","303-744-1065","ksiegel@southdenver.com",{"name":51,"role":52,"phone":10,"phoneExt":10,"email":10},"Nicolas Palmeri, MD","PRINCIPAL_INVESTIGATOR",{"facility":54,"status":33,"city":55,"state":56,"zip":57,"country":37,"countryCode":38,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"KC Heart and Rhythm Institute","Overland Park","Kansas","66211",{"type":40,"coordinates":59},[60,61],-94.67079,38.98223,{"lat":61,"lon":60},[64,67],{"name":65,"role":23,"phone":10,"phoneExt":10,"email":66},"Rachael Koeppe","Rachael.Koeppe@HCAHealthcare.com",{"name":68,"role":52,"phone":10,"phoneExt":10,"email":10},"Dhanunjaya Lakkireddy, MD",{"facility":70,"status":33,"city":71,"state":72,"zip":73,"country":37,"countryCode":38,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"North Carolina Heart & Vascular Research, LLC","Raleigh","North Carolina","27607",{"type":40,"coordinates":75},[76,77],-78.63861,35.7721,{"lat":77,"lon":76},[80,83],{"name":81,"role":23,"phone":10,"phoneExt":10,"email":82},"Alexander Kasari","alexander.kasari@unchealth.unc.edu",{"name":84,"role":52,"phone":10,"phoneExt":10,"email":10},"Joseph Bumgarner, MD",{"type":86,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[88],{"name":89,"class":90},"NAMSA","OTHER","100611924","mobilization-and-outcomes-after-venous-closure-100611924",false,"NCT07246902","Mobilization and Outcomes After Venous Closure","MOVE - Mobilization and Outcomes After VEnous Closure - A Prospective Registry of Real-World Outcomes\u002FUsage\u002FEvidence for the MYNX CONTROL™ VENOUS Vascular Closure Device 6F-12F","MOVE","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\u002Fcomplications 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 \\\u003C12 months.","ALL",{"count":101,"type":102},300,"ESTIMATED","14 Days","OBSERVATIONAL","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.",[107,108],"Venous Vascular Closure","Electrophysiology Study",[108,110,111,112,107,113,114,115,97,116,117],"Venous closure","Venous access closure","Vascular access closure","Vascular closure device","MYNX CONTROL VENOUS","MOVE Registry","Cardiac Catheterization","MYNX","2026-03-13",{"date":120,"type":121},"2026-03-16","ACTUAL",{"date":123,"type":121},"2025-11-24",{"date":125,"type":102},"2026-08",{"name":5,"class":6},3]