Venous Vascular ClosureMOVENCT07246902
Mobilization and Outcomes After Venous Closure
An observational study of Venous Vascular Closure and Electrophysiology Study, run by Cordis US Corp. at 9 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Venous Vascular Closure, Electrophysiology Study
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 339 participants
- Where
- 9 sitesUnited States
- Study dates
- 24 Nov 2025to 26 Aug 2026
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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.).
Who cannot join
- 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.
- Life expectancy <12 months.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Overlake Medical Center
Bellevue, Washington, 98004
Glenbrook Hospital
Glenview, Illinois, 60026
Baptist Health Lexington
Lexington, Kentucky, 40503
South Denver Cardiology
Littleton, Colorado, 80210
Cedars Sinai Medical Center
Los Angeles, California, 90048
AdventHealth Orlando
Orlando, Florida, 32803
KC Heart and Rhythm Institute
Overland Park, Kansas, 66211
Stanford University School of Medicine
Palo Alto, California, 94304
North Carolina Heart & Vascular Research, LLC
Raleigh, North Carolina, 27607
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Venous Vascular Closure, Electrophysiology Study
- Being tested
- MYNX CONTROLTM VENOUS Vascular Closure Device
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MYNX CONTROLTM VENOUS Vascular Closure DeviceDevice
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| MCV VCD Treatment | 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. Receives: Device: MYNX CONTROLTM VENOUS Vascular Closure Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From time of index procedure through end of following day (within 48 hours)
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
Measured: From time of study device introduction at first access site through 14 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start24 Nov 2025
- Primary completion26 Aug 2026
- Study completion26 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous Vascular ClosureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 339 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- Cordis US Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07246902
- Sponsor's protocol ID
- P25-8302
- Acronym
- MOVE
- Status last verified
- Sep 2026
- First submitted
- 13 Nov 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07246902
- Acronym / sponsor ID
- MOVE / P25-8302
- Conditions
- Venous Vascular Closure, Electrophysiology Study
- Keywords
- Electrophysiology Study, Venous closure, Venous access closure, Vascular access closure, Venous Vascular Closure, Vascular closure device, MYNX CONTROL VENOUS, MOVE Registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 339 participants (actual)
- Lead sponsor
- Cordis US Corp.Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 26 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 24 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCV VCD Treatment | – | Device: MYNX CONTROLTM VENOUS Vascular Closure DeviceSubjects 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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.).
Key exclusion criteria (5 listed)
- 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.
- Life expectancy <12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MYNX CONTROLTM VENOUS Vascular Closure 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. | Device | MCV VCD Treatment |
Primary outcome
Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications
Time frame: From time of index procedure through end of following day (within 48 hours)
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
Rate of access-site complications
Time frame: From time of study device introduction at first access site through 14 days post-procedure
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Vascular Closure and Electrophysiology Study, run by Cordis US Corp. at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications (time frame: From time of index procedure through end of following day (within 48 hours)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.