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Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt

NCT00442364 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-04-21

Study results available
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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).

Conditions

  • Varicose Veins

Interventions

DRUG

Polidocanol (1%) Microfoam (Varisolve)

Varisolve polidocanol 1% microfoam, maximum of 20ml injected into affected great saphenous vein.

PROCEDURE

Endovenous Microfoam Occlusion

Varisolve® polidocanol microfoam injection under duplex guidance to fill proximal and distal great saphenous vein and varicose tributaries.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Janet Rush, MD · BTG International Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-06-30
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442364 on ClinicalTrials.gov