Mobilization and Outcomes After Venous Closure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCordis US Corp.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able and willing to provide informed consent and to complete a follow-up visit at 14 ± 7 days post-procedure.
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.
Individuals who are candidates to have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.
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.).
Disqualifiers
Presence of bruit, palpable aneurysm, significant candida or groin infection.
Prior to closure, presence of hematoma in the accessed limb.
Currently involved in any other clinical trial that may interfere with the outcomes of this study as determined by the Investigator.
Planned use of other closure devices or techniques other than MYNX CONTROL™ VENOUS VCD 6F-12F.
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
MYNX CONTROLTM VENOUS Vascular Closure Device
DeviceThe 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. MCV 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. The 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.
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: MCV VCD Treatment1 intervention
Trial outcomes
Primary outcomes
1
Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications
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
Time frame
From time of index procedure through end of following day (within 48 hours)2
Rate of access-site complications
Rate of access-site complications, assessed per standard of care, through 14 days post-procedure, including: * Access Site-Related Hematoma \> 6 cm documented by ultrasound * Local Access Site Infection confirmed by culture and sensitivity, treated with intramuscular or oral antibiotics * Allergic Reaction * Access site-related bleeding requiring transfusion, surgical intervention, or rehospitalization * 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 * Ipsilateral deep vein thrombosis, documented by ultrasound
Time frame
From time of study device introduction at first access site through 14 days post-procedureOther outcomes
1
Time to Ambulation
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.
Time frame
From end of index procedure until time before hospital discharge (usually within ~24 hours of procedure)2
Time to Discharge
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.
Time frame
From end of index procedure until time of hospital discharge (usually within ~24 hours of procedure)3
Time to Hemostasis
Defined as elapsed time (in minutes) between removal of each MCV VCD and first observed and confirmed venous hemostasis (per access site analysis).
Time frame
From time of index procedure until time before hospital discharge (usually within ~24 hours of procedure)4
SDD sustained MCV VCD success
Defined as the proportion of subjects who did not require hospital intervention within 14 days post-procedure due to access site-related complications
Time frame
From end of index procedure through 14 days post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Cordis US Corp.
Lead sponsor
NAMSA
Collaborator
Source ClinicalTrials.gov