Overview
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.
Description
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.
Eligibility
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.