CompletedPhase 4

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

United States208 participantsStarted 2015-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Assessment of Venous Thrombosis

Timeframe: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

Bleeding or Vascular Related Complications

Timeframe: Subjects will be followed up until their discharge from the hospital, and expected average of 24 hours

Device/Procedure Failure

Timeframe: intraoperative

Trial details

NCT IDNCT02438475

SponsorMedstar Health Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-08

Results submitted2020-10-23

View on ClinicalTrials.gov More Cardiac Diagnostic Procedure trials