Phase 4
N=208
The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure
Cardiac Diagnostic Procedure · Cardiac Interventional Procedure · Femoral Access Site Closure
Bottom Line
View on ClinicalTrials.gov: NCT02438475 ↗Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcome: Primary: Assessment of Venous Thrombosis — 0; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Mynx Vascular Closure System (Device); Manual Compression (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medstar Health Research Institute
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Venous Thrombosis |
0; 0 | — |
| PRIMARY Bleeding or Vascular Related Complications |
0; 0 | — |
| PRIMARY Device/Procedure Failure |
0; 0 | — |
Summary
Evaluate the safety of the MynxGrip™ extravascular sealant for common femoral vein closure following both diagnostic and interventional procedures as assessed by clinical and imaging criteria.
Eligibility Criteria
Inclusion Criteria
- Patients > 18 years of age scheduled for a percutaneous diagnostic or interventional procedure that have either a 5, 6, or 7F sheath placed in the common femoral vein.
Exclusion Criteria
- Patient has a history of a bleeding disorder
- Previous history of venous thrombosis or thromboembolism
- Patient is pregnant or lactating
- Patient has a known severe allergy to contrast medium
- Patient has a known allergy to PEG
- Patient is known to require an extended hospitalization or re-hospitalization (e.g. patient is undergoing coronary artery bypass graft (CABG) surgery) or patient is scheduled to have a CABG surgery 1) attempts at venous access were attempted in the target vein 10. Patient has intra-procedural bleeding around the access site prior to sheath removal 11. Critically ill patients requiring intravenous vasopressors for blood pressure stabilization 12. Ipsilateral femoral artery puncture or sheath insertion 13. Glycoprotein IIb/IIIIa use 14. Any bleeding or vascular access-site complication evident pre-venous closure
Data sourced from ClinicalTrials.gov (NCT02438475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.