Mobilization and Outcomes After Venous Closure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorCordis US Corp.
About this trial
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.
Eligibility criteria
Qualifiers
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.).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- MYNX CONTROLTM VENOUS Vascular Closure Device
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Cordis US Corp.
Lead sponsor
NAMSA
Collaborator
Source ClinicalTrials.gov