Phase 4
Completed 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
Source: ClinicalTrials.gov NCT02438475 ↗
Enrolled (actual)
208
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Assessment of Venous Thrombosis — 0; 0 Participants
◆ Published Evidence
Highly cited
2,290citations · ~100 / year
Preventing complications of central venous catheterization.
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.
Linked Publications (5)
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Preventing complications of central venous catheterization.
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Association between use of bleeding avoidance strategies and risk of periprocedural bleeding among patients undergoing percutaneous coronary intervention.
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The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx.
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Local venous thrombosis after cardiac catheterization.
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Risk of local adverse events following cardiac catheterization by hemostasis device use - phase II.
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 | — |
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) and the linked publication. 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. Informational only — not medical advice.