CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 208 enrolled
Drug / intervention
Mynx Vascular Closure System +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02438475
NCT02438475Phase 4Completed
CompareCT.gov

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

Medstar Health Research Institute·interventional·Posted May 8, 2015·Updated Nov 18, 2020

In Brief

A Phase 4 clinical trial evaluating Mynx Vascular Closure System and Manual Compression for Cardiac Diagnostic Procedure and 2 related conditions. Completed, enrolled 208 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiac Diagnostic Procedure, Cardiac Interventional Procedure, Femoral Access Site Closure
CountriesUnited States
CollaboratorsCardinal Health

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 8, 2015
Enrollment StartJun 1, 2015
Primary CompletionAug 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 11.2 years ago

Interventions

Mynx Vascular Closure Systemdevice

MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.

Manual Compressionother

manual pressure applied to your groin for approximately 5-10 minutes