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

SexALL

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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.

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