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NCT Number: NCT07246902

Mobilization and Outcomes After Venous Closure

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.

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Key information

Conditions

Venous Vascular Closure Electrophysiology Study

Sex eligibility

All sexes

Study type

Observational

Primary location

South Denver Cardiology, Littleton, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.).

Exclusion criteria

  • 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.

Treatment and study plan

MYNX CONTROLTM VENOUS Vascular Closure Device

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.

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.

Primary outcomes

  1. 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

  2. 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

Other outcomes

  1. Time to Ambulation

    Time frame: From end of index procedure until time before hospital discharge (usually within ~24 hours of procedure)

    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.

  2. Time to Discharge

    Time frame: From end of index procedure until time of hospital discharge (usually within ~24 hours of procedure)

    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.

  3. Time to Hemostasis

    Time frame: From time of index procedure until time before hospital discharge (usually within ~24 hours of procedure)

    Defined as elapsed time (in minutes) between removal of each MCV VCD and first observed and confirmed venous hemostasis (per access site analysis).

  4. SDD sustained MCV VCD success

    Time frame: From end of index procedure through 14 days post-procedure

    Defined as the proportion of subjects who did not require hospital intervention within 14 days post-procedure due to access site-related complications

  5. Device success evaluated at the end of the procedure

    Time frame: End of index procedure

    Defined as the ability to deploy the delivery system and deliver the PEG component to achieve hemostasis at each access site

  6. Procedural Success

    Time frame: From end of index procedure through 14 days post-procedure

    Defined as the attainment of final hemostasis at all venous access sites without major venous access site closure-related complications through 14 days

  7. Procedural Time

    Time frame: Index procedure

    Defined as time of first sheath insertion until the time of removal of final MCV VCD.

  8. Recovery room time

    Time frame: From time of transfer to recovery room post-discharge to time of discharge (usually within ~24 hours of procedure)

    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.

  9. Analysis of Cost Effectiveness - Comprehensive summary of clinical outcomes, resource utilization, economic proxies, patients reported outcomes and CPT codes

    Time frame: From start time of index procedure through 14 days post-procedure

    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

  10. Incidence of urinary catheter usage

    Time frame: From start time of index procedure through end time of index procedure

    Number/rate of patients with urinary catheters used during the procedure

  11. Incidence of protamine usage

    Time frame: From start time of index procedure through end time of index procedure

    Incidence of protamine usage during the procedure

  12. Medication Usage

    Time frame: From pre-procedure though study exit/follow-up visit (14 +/- 7 days post-procedure)

    Rate of patients who are administered anti-platelet, anti-coagulant, anti-thrombotic, local anesthetic, protamine or pain medication

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer Lee

CONTACT

[email protected]

559-307-7753

Rajesh Nathan

CONTACT

[email protected]

908-528-3931

Sponsors and collaborators

Lead sponsor

Cordis US Corp.

Industry

Collaborators

  • NAMSA

Registry information

Official study 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

Acronym: MOVE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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