Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Cordis US Corp.
With
NAMSA
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.
Age
Any age
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Able and willing to provide informed consent and to complete a follow-up visit at 14 ± 7 days post-procedure.
2. 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.
3. Individuals who are candidates to have their venous access site(s) closed with MYNX CONTROL™ VENOUS VCD 6F-12F per IFU.
4. 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.).
You may not be if
1. Presence of bruit, palpable aneurysm, significant candida or groin infection.
2. Prior to closure, presence of hematoma in the accessed limb.
3. Currently involved in any other clinical trial that may interfere with the outcomes of this study as determined by the Investigator.
4. Planned use of other closure devices or techniques other than MYNX CONTROL™ VENOUS VCD 6F-12F.
5. Life expectancy \<12 months.
Clareo Health | Mobilization and Outcomes After Venous Closure
