At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 60 enrolled
Drug / intervention
Polidocanol (1%) Microfoam (Varisolve) +1 moredrug
Likely dose
Polidocanol (1%) Microfoam (Varisolve) 20mlfrom 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.
An Open Label Multicenter Safety Study of the Varisolve® Procedure for the Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt
In Brief
A Phase 2 clinical trial evaluating Polidocanol (1%) Microfoam (Varisolve) and Endovenous Microfoam Occlusion for Varicose Veins. Completed, enrolled 60 participants across 7 sites.
Detailed Summary
The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVaricose Veins
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 2007
Enrollment StartMar 2007
Primary CompletionJun 2008
Study CompletionAug 2009
TodayJul 2026
First PostedMar 1, 2007
Enrollment StartMar 1, 2007
Primary CompletionJun 1, 2008
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.3 years ago
Interventions
Polidocanol (1%) Microfoam (Varisolve)drug
Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.
Endovenous Microfoam Occlusionprocedure
Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.