An Open-Label Single-Center Study in Patients With Great Saphenous Vein Incompetence to Investigate the Pharmacokinetic Properties of Polidocanol Endovenous Microfoam (PEM)

Boston Scientific Corporation1 site in 1 country21 target enrollmentAugust 2011

ConditionsVaricose Veins

InterventionsPolidocanol Endovenous Microfoam (PEM)

DrugsPolidocanol Endovenous Microfoam (PEM)

Overview

Phase: Phase 1
Intervention: Polidocanol Endovenous Microfoam (PEM)
Conditions: Varicose Veins
Sponsor: Boston Scientific Corporation
Enrollment: 21
Locations: 1
Primary Endpoint: Weight-adjusted Polidocanol Cmax (Serum)
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the pharmacokinetic profile of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM), an investigational treatment for varicose veins.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

January 2012

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Boston Scientific Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female; age 18 to 75 years
•Superficial venous disease where SFJ incompetence is the predominant source of reflux (reflux \> 0.5 seconds on duplex ultrasonography) associated with incompetence of the great saphenous vein (GSV) or other major accessory vein
•Expected need for microfoam of 10 mL to fill the incompetent GSV and tributaries (minimum trunk vein diameter of 6mm)
•Clinically normal renal and hepatic function on serum chemistry
•Ability to comprehend and sign an informed consent document in English

Exclusion Criteria

•Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
•Clinically significant abnormal ECG or clinical condition which may affect interpretation of ECG, for example, history of Long QT Syndrome, Brugada Syndrome, electronic cardiac pacemaker, chronic atrial fibrillation, recent myocardial infarction or congestive heart failure.
•Patients taking QT prolonging medications
•Any of the following findings on screening ECG:
•QRS \> 110 ms
•HR \< 45 bpm
•HR \> 100 bpm
•QTcF \> 470 ms
•PR \> 220 ms
•Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders)