The Safety and Efficacy of an Extravascular, Water-Soluble Sealant for Venous Access-Site Closure
Completed · Phase 4
Conditions studied: Cardiac Diagnostic Procedure, Cardiac Interventional Procedure, Femoral Access Site Closure
In brief
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.
Key facts
- Study ID
- NCT02438475
- Run by
- Medstar Health Research Institute
- People needed
- 208
- Starts
- 2015-06-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2020-11-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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 qualify if…
- 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
Where it is running
- MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
- MedStar Southern Maryland Hospital — Clinton, Maryland, United States
Full record on ClinicalTrials.gov
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