Last updated on December 2016

The Safety and Efficacy of an Extravascular Water-Soluble Sealant for Venous Access-Site Closure


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Femoral Access Site Closure | Cardiac Interventional Procedure | Cardiac Diagnostic Procedure
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    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.

You may not be eligible for this study if the following are true:

  • 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 <30 days following the procedure) 9. Multiple (>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

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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