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

Primary Purpose

Venous Insufficiency

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RF Ablation (ClosureRFS Stylet)
Sponsored by
Medtronic Endovascular
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Insufficiency focused on measuring IPV, RadioFrequency, QOL

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Varicosity Vein Center
  • Vein Care Pavilion of the South
  • Allegiance Vascular Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

RF ablation with ClosureRFS Stylet

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)
CEAP Classification at Month 6 will be reported.
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.

Full Information

First Posted
February 24, 2010
Last Updated
March 24, 2017
Sponsor
Medtronic Endovascular
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1. Study Identification

Unique Protocol Identification Number
NCT01079598
Brief Title
RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study
Acronym
TRIPLE
Official Title
A Prospective Multicenter Study on the Treatment of Incompetent Perforators With the VNUS® Closure Radiofrequency Stylet
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Insufficiency
Keywords
IPV, RadioFrequency, QOL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Arm Description
RF ablation with ClosureRFS Stylet
Intervention Type
Device
Intervention Name(s)
RF Ablation (ClosureRFS Stylet)
Other Intervention Name(s)
RFS, RFS Stylet, ClosureRFS Stylet
Intervention Description
Bipolar energy radiofrequency ablation with RFS stylet
Primary Outcome Measure Information:
Title
Quality of Life and Clinical Assessments Compared to Pretreatment Baseline.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cessation of Flow Through the Perforator Vein
Description
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.
Time Frame
6 months
Title
CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)
Description
CEAP Classification at Month 6 will be reported.
Time Frame
6 months
Title
Cessation of Flow Reflux Through the Perforator Vein
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Hasenbank, PhD
Organizational Affiliation
Medtronic
Official's Role
Study Director
Facility Information:
Facility Name
Varicosity Vein Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Facility Name
Vein Care Pavilion of the South
City
Evans
State/Province
Georgia
ZIP/Postal Code
30809
Country
United States
Facility Name
Allegiance Vascular Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

RFS (Radiofrequency Stylet) - Radiofrequency Perforator Vein Treatment Study

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