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

This study has been terminated.
(Low enrollment)
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular
ClinicalTrials.gov Identifier:
NCT01079598
First received: February 24, 2010
Last updated: March 24, 2017
Last verified: March 2017
  Purpose
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).

Condition Intervention
Venous Insufficiency Device: RF Ablation (ClosureRFS Stylet)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet

Further study details as provided by Medtronic Endovascular:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Cessation of Flow Through the Perforator Vein [ Time Frame: 6 months ]
    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.

  • CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology) [ Time Frame: 6 months ]
    CEAP Classification at Month 6 will be reported.

  • Cessation of Flow Reflux Through the Perforator Vein [ Time Frame: 6 months ]
    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.


Enrollment: 8
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079598

Locations
United States, Alabama
Varicosity Vein Center
Birmingham, Alabama, United States, 35213
United States, Georgia
Vein Care Pavilion of the South
Evans, Georgia, United States, 30809
United States, Michigan
Allegiance Vascular Health
Jackson, Michigan, United States, 49201
Sponsors and Collaborators
Medtronic Endovascular
Investigators
Study Director: Melissa Hasenbank, PhD Medtronic
  More Information

Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01079598     History of Changes
Other Study ID Numbers: RFS-09-01
Study First Received: February 24, 2010
Results First Received: January 31, 2017
Last Updated: March 24, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.

Keywords provided by Medtronic Endovascular:
IPV
RadioFrequency
QOL

Additional relevant MeSH terms:
Venous Insufficiency
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 18, 2017