Mobilization and Outcomes After Venous Closure

Conditions

• Electrophysiology Study
• Venous Vascular Closure

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.

Study Details

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.

Key Dates

Start date

Nov 24, 2025

Status verified

Mar 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2026

Study Design

Enrollment

300 participants (estimated)

Arms

• Arm: 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.

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) ]

Central Contacts

• Rajesh Nathan
  908-528-3931
  [email protected]
• Jennifer Lee
  559-307-7753
  [email protected]

Locations (3)

Find similar trials in Littleton, CO

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  Recruiting · University of Minnesota · Washington D.C., District of Columbia