A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Venous Insufficiency
- Sponsor
- Medtronic Endovascular
- Enrollment
- 8
- Locations
- 3
- Primary Endpoint
- Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to demonstrate that patients will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of incompetent perforator veins (IPVs).
Detailed Description
The purpose of this study is to demonstrate that patients who have competent great saphenous vein (GSV) and short saphenous vein (SSV) or have undergone prior successful endovenous treatment of an incompetent GSV and/or SSV but continue to demonstrate clinical symptoms of peripheral venous insufficiency resulting from incompetent perforator veins (IPVs) will improve the immediate treatment outcomes from successive radiofrequency ablation (RFA) of IPVs veins.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male and female, ages 18 to 80 years, from all racial and ethnic origin
- •Have the ability to understand the requirements of the study, provide written informed consent to participate, and agree to abide by the study requirements
- •Available for all the follow-up visits and in a physical condition allowing ambulation after the procedure
- •Incompetent GSV and/or SSV in the target limb has been treated at least 3 months before study enrollment or competent GSV and SSV at time of treatment
- •CEAP 4 - 6 classification
- •DUS reflux of ≥0.35 sec or more of the target IPV and/or an intra-fascia diameter of ≥0.3 mm
Exclusion Criteria
- •Acute (at Screening) superficial venous thrombosis of either limb
- •Acute (within the prior 3 months) deep venous thrombosis or phlebitis in either limb
- •Complete or near complete deep venous obstruction documented by ultrasound
- •Previously participated in any study involving ClosureRFS
- •Actively participated in any other investigational study within 30 days of enrollment into this study
- •Pregnant at the time of treatment. Status verified by pregnancy test via blood or urine for women ≤ 55 years old.
- •Having a medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance, including all required study follow-up
- •Have any condition that, in the opinion of the Investigator, would jeopardize the safety of the patient or affect the validity of the trial results
- •Have a history of excessive alcohol consumption or any use of illegal drugs rendering the patient unreliable, or at risk during this trial
- •Have undergone major surgery which may result in abnormalities of the target body area, reasonably suspected to compromise the study outcomes
Outcomes
Primary Outcomes
Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.
Time Frame: 6 months
QOL and clinical assessments measured by periodic CIVIQ2 and VCSS assessments were planned to be compared at each follow-up visit to pretreatment baseline. However, with the very low enrollment and limited data available, analysis and study results are inconclusive.
Secondary Outcomes
- Cessation of Flow Through the Perforator Vein(6 months)
- CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)(6 months)
- Cessation of Flow Reflux Through the Perforator Vein(6 months)