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

A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet

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).

Study Overview

• Status: Terminated
• Conditions: Venous Insufficiency
• Intervention / Treatment: Device: RF Ablation (ClosureRFS Stylet)

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35213
      • Varicosity Vein Center
  • Georgia
    • Evans, Georgia, United States, 30809
      • Vein Care Pavilion of the South
  • Michigan
    • Jackson, Michigan, United States, 49201
      • Allegiance Vascular Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment; RF ablation with ClosureRFS Stylet	Device: RF Ablation (ClosureRFS Stylet); Bipolar energy radiofrequency ablation with RFS stylet; Other Names: RFS; RFS Stylet; ClosureRFS Stylet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cessation of Flow Through the Perforator Vein	Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.	6 months
CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)	CEAP Classification at Month 6 will be reported.	6 months
Cessation of Flow Reflux Through the Perforator Vein	Cessation of incompetent flow and reflux is defined as the absence of blood flow within the treated segment of the perforator vessel at the level the vessel crosses the superficial fascia. Key measures that will be used to evaluate the intervention that are a focus of the study.	6 months

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Study Director: Melissa Hasenbank, PhD, Medtronic

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): January 1, 2011
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: February 24, 2010
• First Submitted That Met QC Criteria: March 1, 2010
• First Posted (Estimate): March 3, 2010

Study Record Updates

• Last Update Posted (Actual): May 5, 2017
• Last Update Submitted That Met QC Criteria: March 24, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: IPV; QOL; RadioFrequency
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Venous Insufficiency
• Other Study ID Numbers: RFS-09-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Out of a planned 225 patient subject size, a total of 8 subjects were enrolled with 10 limbs treated. As a result of stagnant enrollment in the study, a decision was made to terminate the study.