Clinical trial NCT01079598: RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study
Official title: A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Venous Insufficiency
Keywords: IPV
RadioFrequency
QOL
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2010-03-03
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* Have undergone an invasive procedure of the target body area (e.g., needle biopsy or surgical procedure) within 30 days of enrollment into this study
* Known incompatibility, such as an allergic reaction to anesthetics to be used in the incompetent perforator vein treatment
* Patients requiring hyperbaric therapy involving the treated limb during the 6 month post treatment follow-up period
* Great toe pressure measurement of ≤ 70 mmHg
* CEAP 6 classified patients receiving high dose steroid medication or the following medications that interfere with normal mechanisms of wound healing, e.g. glucocorticoids, non-steroidal anti-inflammatory drugs (NSAIDs), anti-neoplastic and immunosuppressive drugs, and others like, colchicine and penicillamine.
* Expressing a body mass index (BMI) of ≥ 35.

Primary outcomes:
measure: Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.
timeFrame: 6 months
Secondary outcomes:
measure: Cessation of Flow Through the Perforator Vein
timeFrame: 6 months
measure: CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)
timeFrame: 6 months
measure: Cessation of Flow Reflux Through the Perforator Vein
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Varicosity Vein Center
state: Alabama
city: Evans
country: United States
facility: Vein Care Pavilion of the South
state: Georgia
city: Jackson
country: United States
facility: Allegiance Vascular Health
state: Michigan
Study officials:
affiliation: Medtronic
name: Melissa Hasenbank, PhD
role: STUDY_DIRECTOR
References: