Venous Insufficiency
Conditions
Keywords
IPV, RadioFrequency, QOL
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.
Interventions
DEVICERF Ablation (ClosureRFS Stylet)
Bipolar energy radiofrequency ablation with RFS stylet
Sponsors
Medtronic Endovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life and Clinical Assessments Compared to Pretreatment Baseline. | 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
| Measure | Time frame | Description |
|---|---|---|
| Cessation of Flow Through the Perforator Vein | 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) | 6 months | CEAP Classification at Month 6 will be reported. |
| Cessation of Flow Reflux Through the Perforator Vein | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| Region of Enrollment United States | 8 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 1 / 8 |
Outcome results
Primary
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.
Time frame: 6 months
Population: Analysis was not able to be completed due to very low enrollment and limited data available. No results available.
Secondary
CEAP Classification (Clinical Severity, Etiology or Cause, Anatomy, Pathophysiology)
CEAP Classification at Month 6 will be reported.
Time frame: 6 months
Population: Analysis was not able to be completed due to very low enrollment and limited data available. No results available.
Secondary
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.
Time frame: 6 months
Population: Analysis was not able to be completed due to very low enrollment and limited data available. No results available.
Secondary
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.
Time frame: 6 months
Population: Analysis was not able to be completed due to very low enrollment and limited data available. No results available.