RecruitingNot Applicable

Mobilization and Outcomes After Venous Closure

United States300 participantsStarted 2025-11-24

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of patients with same day discharge (SDD) and without subsequent hospitalization/intervention for access-site complications

Timeframe: From time of index procedure through end of following day (within 48 hours)

Rate of access-site complications

Timeframe: From time of study device introduction at first access site through 14 days post-procedure

Trial details

NCT IDNCT07246902

SponsorCordis US Corp.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-08

Contact for this trial

Rajesh Nathan

908-528-3931 rajesh.nathan@cordis.com

View on ClinicalTrials.gov More Venous Vascular Closure trials