Overview

This trial is active, not recruiting.

Conditions great saphenous disease, venous reflux
Treatment rf ablation (closurefast)
Phase phase 4
Sponsor VNUS Medical Technologies, A Covidien Company
Start date April 2006
End date December 2012
Trial size 396 participants
Trial identifier NCT00842296, CLF-05-03

Summary

The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
Single Arm with CLF Catheter
rf ablation (closurefast) CLF
Segmental RF Ablation with the CLF catheter

Primary Outcomes

Measure
Vein occlusion rate
time frame: 5yr

Secondary Outcomes

Measure
Status of clinical signs and symptoms of lower limb venous disease
time frame: 5 yr

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

Inclusion Criteria: - Age between 18 and 80 years of age at the time of enrollment - Symptomatic lower limb venous disease involving the GSV Exclusion Criteria: - Thrombosis in the vein segment to be treated - Known or suspected pregnancy or actively breast feeding at time of treatment

Additional Information

Official title ClosureFAST - Endovascular Radiofrequency Great Saphenous Vein Treatment Using a Catheter With an Integrated Heating Element
Description The purpose of this study is to confirm that the ClosureFAST system can be used as an alternative to the current ClosurePlus catheter for treating the GSV and to accumulate pivotal data for optimization of the operating parameters. The results from this study will be used to further evaluate the risks and benefits of the ClosureFAST device and to obtain clinical evidence that the treatment provides effective and durable clinical outcomes.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by VNUS Medical Technologies, A Covidien Company.