RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study (TRIPLE)

Medtronic

Status

Terminated

Conditions

Venous Insufficiency

Treatments

Device: RF Ablation (ClosureRFS Stylet)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01079598

RFS-09-01

Details and patient eligibility

About

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).

Full 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.

Enrollment

8 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.