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Mobilization and Outcomes After Venous Closure

NCT07246902 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-03-16

No results posted yet for this study

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.

Conditions

  • Venous Vascular Closure
  • Electrophysiology Study

Interventions

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. 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.

Sponsors & Collaborators

  • NAMSA

    collaborator OTHER

  • Cordis US Corp.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2026-08-31
Completion
2026-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07246902 on ClinicalTrials.gov